Mgr, Regulatory Consulting

2 weeks ago


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 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

  • Contributes to planning for regulatory submissions in assigned region/country/project.
  • Responsible for day to day management of project teams and projects.
  • Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
  • Acts as a representative of the regulatory department with other departments.
  • Supports business development, including generation of repeat business from existing clients and proposal development.
  • Develops, reviews, and monitors project budgets; reviews client invoicing.
  • Monitors personal utilization and utilization of direct reports.
  • Acts as a key point of contact for clients and regulatory authorities.
  • Provides regulatory advice to Company associates.
  • Conducts regulatory research on projects as needed.
  • Provides strategic and operational advice to clients.
  • Arranges, leads, and reports on client and regulatory agency meetings.
  • Writes IND and product registration dossiers, clinical reports, and other regulatory documents. Manages project teams and preparation of regulatory submissions for conduct of INDs, product registrations, and post approval maintenance activities.
  • Acts as a resource for technical knowledge.
  • Participates in quality improvement efforts to increase overall operational efficiency.
  • Contributes to the building of regulatory systems and infrastructure needed for GRAS.
  • Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees.
  • Develops solutions to complex problems.
  • Provides internal training in appropriate areas of expertise to other departments.

Qualifications

What we’re looking for

  • BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field or moderate pharmaceutical/medical device related experience. Moderate experience in regulatory.
  • Demonstrated experience in contributing to the preparation of regulatory submissions including for example IND, PMA, NDA, MAA, and CTD, including electronic submissions. Experience in niche submissions such as ODD, PIP/PMP an advantage.
  • Comprehensive regulatory knowledge and understanding of pharmaceutical and or medical device product development.
  • 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 and budgeting skills.
  • Good people management, project management, problem-solving, and decision-making 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...


  • Montreal, Quebec, Québec, Canada Knight Therapeutics Full time

    Knight Therapeutics Inc., headquartered in Montreal, is a pan-American (ex-US) specialty pharmaceutical company helping patients in Canada and 10 countries in Latin America. Knight Therapeutics Inc. is focused on acquiring, in licensing, out-licensing, marketing, and commercializing innovative prescription pharmaceuticals in Canada and Latin...

  • Pharmacokineticist

    4 months ago


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

    Description Pharmacokineticist 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...


  • 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...

  • Trust Services Expert

    2 months ago


    Quebec City, Quebec, Québec, Canada National Bank Full time

    As a Trust Services Expert, you participate in the sector's mission, which is mainly to offer trust services to individuals and specialized advice to affluent clients. For more than 90 years, National Bank Trust has been recognized in the industry as a fiduciary partner for generations of clients. We stand out for our know-how and professionalism marked...


  • Montreal, Quebec, Québec, Canada LanceSoft, Inc. Full time

    Hybrid 3 days a week.Role: Sitting with in the Technology Change Enablement Team comprised of: 1)Operational Change Enablement: defining the Firm's Technology Change controls and procedures, provisioning oversight and education on Change Enablement practices, enforcing adherence to Change process requirements, KPI / KRI management and monitoring...

  • Validation Supervisor

    1 month ago


    Montreal, Quebec, Québec, Canada Brunel Full time

    IntroductionWe are currently recruiting for a Bilingual (Fr/En) Validation Supervisor for our client. As a Validation Supervisor at a leading pharmaceutical company specializing in sterile products, you will play a crucial role in ensuring that all site processes, equipment, and systems adhere to stringent regulatory standards. You will lead a team of...


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

    Description Director of Operations II, RWLP 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. Every day we perform better because of how we work together, as one...


  • Montreal, Quebec, Québec, Canada QUANTEAM 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,...

  • Controller

    5 months ago


    Montréal, Quebec, Québec, Canada Fed Finance Full time

    Founded in 2001, Fed Finance is a recruitment agency that is specialized in accounting and finance positions. Our consultants are finance experts and speak your language. We select the best candidates for temporary and permanent positions. We are committed to working with you throughout your job search and beyond!client dans le secteur de l'hotellerie et...


  • Montreal, Quebec, Québec, Canada Tata Consultancy Services Full time

    About TCS:Tata Consultancy Services is an IT services, consulting, and business solutions organization that has been partnering with many of the world’s largest businesses in their transformation journeys for over 55 years. Its consulting-led, cognitive powered portfolio of business, technology, and engineering services and solutions is delivered through...


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

    WHO WE ARE:As the founding entity of RAINBOW PARTNERS, Quanteam is a consulting firm specializing in the fields of 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:...

  • Business Analyst

    4 days ago


    Montreal, Quebec, Québec, Canada Astek Full time

    The Astek GroupFounded in France in 1988, Astek is a global player in engineering and technology consulting. With its expertise in various industrial and tertiary sectors, Astek supports its international clients in the intelligent deployment of their products and services, as well as in the implementation of their digital transformation.Since its inception,...


  • 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. 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 investments in...

  • SDLC Governance lead

    1 month ago


    Montreal, Quebec, Québec, Canada Synechron Full time

    We areAt Synechron, we believe in the power of digital to transform businesses for the better. Our global consulting firm combines creativity and innovative technology to deliver industry-leading digital solutions. Synechron’s progressive technologies and optimization strategies span end-to-end Artificial Intelligence, Consulting, Digital, Cloud & DevOps,...


  • 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...


  • Montreal, Quebec, Québec, Canada Synechron Full time

    Nous sommesChez Synechron, nous croyons en la puissance du numérique pour transformer les entreprises en mieux. Notre cabinet de conseil mondial allie créativité et technologie innovante pour fournir des solutions numériques leaders du secteur. Les technologies progressistes et les stratégies d'optimisation de Synechron couvrent de bout en bout...


  • Montreal, Quebec, Québec, Canada Synechron Full time

    At Synechron, we believe in the power of digital to transform businesses for the better. Our global consulting firm combines creativity and innovative technology to deliver industry-leading digital solutions. Synechron’s progressive technologies and optimization strategies span end-to-end Artificial Intelligence, Consulting, Digital, Cloud & DevOps, Data,...


  • 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...