Regulatory Consultant

1 month ago


Quebec City Quebec, Québec, Canada Syneos Health Full time

Description

Regulatory Consultant

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

JOB RESPONSIBILITIES

  • Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
  • Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions.
  • Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies.
  • Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.
  • Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems.
  • Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
  • Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.
  • Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.
  • Prepare training materials and share best practices in the regulatory area, both internally and externally.
  • Participate as regulatory support in internal or external project audits.
  • Participate as regulatory support on internal cross-functional initiatives.
  • Contribute to the creation and/or maintenance of SOPs and other process related documentation

as required.

  • Provide support in oversight to team members in the execution of their project responsibilities.
  • Capable of identifying when to ensure line support required to provide additional guidance and

direction.

  • Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.

Qualifications

What we’re looking for

  • BS or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. Moderate pharmaceutical/medical device related experience.
  • Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, PMA, NDA, MAA, and CTD, including electronic submissions.
  • Excellent interpersonal / communication skills including excellent written and verbal communication skills.
  • Excellent customer service skills, with the ability to work both as a team member and independently.
  • Good quality management skills.
  • Advanced skills in Microsoft Office Applications.
  • Ability to interact with staff from multiple departments and offices to establish project standards.
  • Good initiative, adaptability, and pro-activity.
  • Strong analytical skills, good attention to detail.
  • Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
  • Fluent in speaking, writing, and reading English.

Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.



  • Quebec City, Quebec, Québec, Canada Syneos Health Full time

    Description Manager, Regulatory Consulting Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...


  • Quebec City, Quebec, Québec, Canada Syneos Health Full time

    Description Regulatory Affairs Associate Director Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the...


  • Quebec City, Quebec, Québec, Canada Homewood Health Part time

    Homewood Health is Canada's leader in mental health and addiction services and we offer the most comprehensive and integrated continuum of services available in Canada. We are redefining mental health and addiction services to help Canadians live healthier, more productive and more fulfilling lives. Homewood Health is seeking registered mental health...


  • Montreal, Quebec, Québec, Canada QUANTEAM - North America Full time

    About the Company:As the founding entity of RAINBOW PARTNERS, Quanteam is a consulting firm specializing in Banking, Finance, and Financial Services. Guided by our core values of closeness, teamwork, diversity, and excellence, our team of 1,000 expert consultants, representing 35 different nationalities, collaborates across 10 international offices: Paris,...

  • IT Business Analyst

    2 weeks ago


    Montreal, Quebec, Québec, Canada QUANTEAM - North America Full time

    About the Company:As the founding entity of RAINBOW PARTNERS, Quanteam is a consulting firm specializing in Banking, Finance, and Financial Services. Guided by our core values of closeness, teamwork, diversity, and excellence, our team of 1,000 expert consultants, representing 35 different nationalities, collaborates across 10 international offices: Paris,...


  • Montreal, Quebec, Québec, Canada Peakhill Capital Full time

    Job DescriptionWe are seeking a self-motivated Commercial Real Estate Analyst to join our dynamic and growing team in Montreal. Peakhill Capital is a commercial real estate capital provider with mortgage investments across all real estate asset classes in Canada. Our equity platform (Peakhill Equity Partners) is an opportunistic equity platform focused on...

  • Python developer

    3 weeks ago


    Montreal, Quebec, Québec, Canada QUANTEAM - North America Full time

    About the Company:As the founding entity of RAINBOW PARTNERS, Quanteam is a consulting firm specializing in Banking, Finance, and Financial Services. Guided by our core values of closeness, teamwork, diversity, and excellence, our team of 1,000 expert consultants, representing 35 different nationalities, collaborates across 10 international offices: Paris,...

  • Mechanical Engineer

    3 weeks ago


    Montreal, Quebec, Québec, Canada VTEK CONSULTANTS INC Full time

    Depuis plus de 25 ans, VTEK Consulting Group Inc. est un leader dans la fourniture de services EPCM, grâce à une équipe talentueuse et diversifiée. Notre vaste expérience dans l'industrie pétrolière et gazière a soutenu notre croissance récente et consolidé notre réputation en tant qu'acteur clé du secteur.Nous sommes actuellement à la...


  • Montreal, Quebec, Québec, Canada Groupe CH Full time

    Raison d’être du posteLe Groupe CH (Canadiens de Montréal, Rocket de Laval, evenko, L’Équipe Spectra, etc.) est à la recherche d'un(e) Spécialiste principal(e), rémunération et avantage sociaux pour contribuer au succès de nombreuses initiatives.Relevant de la Directrice de la rémunération globale, le titulaire du poste joue un rôle de...

  • Conseiller juridique

    2 months ago


    Montreal, Quebec, Québec, Canada Trustii Full time

    An English follows À propos de nousTrustii est un acteur majeur dans l’industrie des services automatisés de vérification d'antécédents et des solutions intelligentes pour la gestion des risques liés aux personnes. Elle propose une plateforme adoptée par des leaders canadiens de la gestion immobilière ainsi que par des équipes RH, de gestion...

  • Full Stack Developer

    3 weeks ago


    Montreal, Quebec, Québec, Canada Synechron Full time

    We areSynechron is a leading global digital transformation consulting firm focused on financial services and technology organizations. Our specialties include end-to-end Artificial Intelligence, Consulting, Digital, Cloud & DevOps, Data, and Software Engineering. Our 13 FinLabs serve as hubs where we innovate and develop cutting-edge business solutionsOur...

  • UI Developer

    3 weeks ago


    Montreal, Quebec, Québec, Canada Synechron Full time

    We areSynechron is a leading global digital transformation consulting firm focused on financial services and technology organizations. Our specialties include end-to-end Artificial Intelligence, Consulting, Digital, Cloud & DevOps, Data, and Software Engineering. Our 13 FinLabs serve as hubs where we innovate and develop cutting-edge business solutions. Our...

  • Regulatory Consultant

    1 month ago


    Quebec City, Canada Syneos Health Full time

    Description Regulatory Consultant Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...


  • Quebec City, Canada Syneos Health Full time

    About Syneos HealthSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Job OverviewWe are seeking an experienced Regulatory Consultant Specialist to contribute to the...


  • Quebec City, Canada Syneos Health Full time

    Description Manager, Regulatory Consulting Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...


  • Quebec City, Canada Syneos Health Full time

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Associate Director to join our team at Syneos Health. This individual will be responsible for contributing to the planning of regulatory submissions, managing project teams, and acting as a representative of the regulatory department.The ideal candidate will have comprehensive regulatory...


  • Quebec City, Canada Syneos Health Full time

    About UsSyneos Health is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. We transform unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.Job OverviewWe are seeking an experienced Regulatory Strategy Director to join our team. This key role will contribute...


  • Quebec City, Canada Syneos Health Full time

    Description Regulatory Affairs Associate Director Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the...

  • Investment Consultant

    7 months ago


    Quebec City, Canada MD Financial Management Full time

    Requisition ID: 159433 Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture. Summary: Reporting to the Regional Manager, as a Investment Consultant, you will assist MD clients and their families in achieving their personal financial goals. Working as a partner with MD’s Specialist Advisors, you will...


  • Quebec City, Canada American Express Global Business Travel Full time

    Amex GBT is a place where colleagues find inspiration in travel as a force for good and - through their work - can make an impact on our industry. We’re here to help our colleagues achieve success and offer an inclusive and collaborative culture where your voice is valued. Ready to explore a career path? Start your journey. As a Travel Counselor,...


  • Quebec City, Canada CIBC Full time

    We’re building a relationship-oriented bank for the modern world. We need talented, passionate professionals who are dedicated to doing what’s right for our clients. At CIBC, we embrace your strengths and your ambitions, so you are empowered at work. Our team members have what they need to make a meaningful impact and are truly valued for who they are...


  • Quebec City, Canada MD Financial Management Full time

    Requisition ID: 182700 Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture. For more than 50 years, MD Financial Management has provided Canada’s physicians and their families with discerning and timely financial guidance. We take pride in knowing physicians best, understanding the challenges and...


  • Quebec City, Canada MD Financial Management Full time

    Requisition ID: 207050 Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture. Imagine an environment that encourages you to bring your best self to work every day. A company committed to your personal development and career aspirations. An employer who not only respects your requirement for life/work...


  • Quebec City, Canada KPMG Full time

    Overview: You’ve got big plans. We have opportunities to match, and we’re committed to empowering you to become a better you, no matter what you do. When you join KPMG you’ll be one of over 219,000 professionals providing audit, tax, advisory and business enablement services across 147 countries. With the support to do things differently, grow...


  • Quebec, Canada, Canada Navacord- Programmed Insurance Brokers Full time

    POSITION OVERVIEW Programmed Insurance Brokers Inc. is seeking a dynamic, experienced, and driven Group Benefits Consultant to lead and expand our market presence in Quebec. This individual will play a key role in establishing and strengthening PIB's foothold in Quebec, building and maintaining strong client relationships, and delivering comprehensive,...


  • Quebec City, Canada EightSix Network Full time

    Job Description Resolute Forest Products, founded more than two centuries ago, is a global leader in the forest products industry. Through the years, it has built more than 20 predecessor companies and supported hundreds of communities. The company owns or operates some 40 facilities, as well as power generation assets, in the United States and...


  • Quebec, Canada CIBC Full time

    We’re building a relationship-oriented bank for the modern world. We need talented, passionate professionals who are dedicated to doing what’s right for our clients. At CIBC, we embrace your strengths and your ambitions, so you are empowered at work. Our team members have what they need to make a meaningful impact and are truly valued for who they are...


  • Quebec City, Canada BMO Financial Group Full time

    8400 boul Henri-Bourassa, #100 Quebec Quebec,G1G 4E2 Delivers exceptional service to BMO customers and prospects. Identifies customer needs and provides advice and guidance regarding financial solutions that are in the best interests of customers. Works collaboratively within the branch and with BMO partners to deliver the desired customer experience and...


  • Quebec City, Canada BMO Financial Group Full time

    1600 boulevard Lebourgneuf Quebec Quebec,G2K 2M4 Delivers exceptional service to BMO customers and prospects. Identifies customer needs and provides advice and guidance regarding financial solutions that are in the best interests of customers. Works collaboratively within the branch and with BMO partners to deliver the desired customer experience and...


  • Quebec City, Canada BMO Financial Group Full time

    2828 boul Laurier Quebec Quebec,G1V 0B9 Delivers exceptional service to BMO customers and prospects. Identifies customer needs and provides advice and guidance regarding financial solutions that are in the best interests of customers. Works collaboratively within the branch and with BMO partners to deliver the desired customer experience and achieve overall...

  • Personal Banker

    1 month ago


    Quebec City, Canada BMO Financial Group Full time

    1600 boulevard Lebourgneuf VILLE DE QUEBEC Quebec,G2K 2M4 Delivers exceptional service to BMO customers and prospects. Identifies customer needs and provides advice and guidance regarding financial solutions that are in the best interests of customers. Works collaboratively within the branch and through various channels with BMO partners to deliver the...


  • Quebec City, Canada BMO Financial Group Full time

    1660 Avenue Jules-Verne Quebec Quebec,G2G 2R5 Delivers exceptional service to BMO customers and prospects. Identifies customer needs and provides advice and guidance regarding financial solutions that are in the best interests of customers. Works collaboratively within the branch and with BMO partners to deliver the desired customer experience and achieve...