Mgr, Regulatory Consulting

2 weeks ago

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 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.

  • Mgr, Regulatory Consulting

    2 months ago

    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 Cl

  • 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...

  • Mgr, Regulatory Consulting

    2 months 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...

  • Mgr, Regulatory Consulting

    2 months ago

    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...

  • Mgr, Regulatory Consulting

    2 months ago

    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...

  • Regulatory Consultant

    3 weeks ago

    Quebec City, Canada Syneos Health Full time

    About the RoleWe are seeking a highly skilled Regulatory Consultant to join our team at Syneos Health. As a key member of our regulatory department, you will be responsible for contributing to the planning and preparation of regulatory submissions, managing project teams, and providing regulatory advice to clients and colleagues.Key...

  • Regulatory Consultant

    3 weeks ago

    Quebec City, Canada Syneos Health Full time

    About the RoleWe are seeking a highly skilled Regulatory Consultant to join our team at Syneos Health. As a key member of our regulatory department, you will be responsible for contributing to the planning and preparation of regulatory submissions, managing project teams, and providing regulatory advice to clients and colleagues.Key...

  • Regulatory Consultant

    1 week ago

    Quebec City, Canada Syneos Health Full time

    About the RoleWe are seeking a highly skilled Regulatory Consultant to join our team at Syneos Health. As a key member of our regulatory affairs team, you will be responsible for contributing to the planning and preparation of regulatory submissions in assigned regions/countries/projects.Key ResponsibilitiesContribute to the preparation of regulatory...

  • Regulatory Consulting Manager

    2 weeks ago

    Quebec City, Canada Syneos Health Full time

    About the RoleWe are seeking a highly skilled Regulatory Consulting Manager to join our team at Syneos Health. As a key member of our regulatory team, you will be responsible for contributing to the planning and preparation of regulatory submissions, including INDs, PMAs, NDAs, and CTDS.Key ResponsibilitiesContribute to the preparation of regulatory...

  • Regulatory Consulting Manager

    1 week ago

    Quebec City, Canada Syneos Health Full time

    About the RoleWe are seeking a highly skilled Regulatory Consulting Manager to join our team at Syneos Health. As a key member of our regulatory department, you will be responsible for contributing to the planning and preparation of regulatory submissions, including INDs, PMAs, NDAs, and CTDS.Key ResponsibilitiesContribute to the planning and preparation of...

  • Mgr, Bioanalysis

    5 months ago

    Quebec City, Canada Syneos Health Clinical Full time

    **Description** **Manager, Bioanalysis** 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...

  • Regulatory Affairs Director

    1 week ago

    Quebec City, Canada Syneos Health Full time

    About the RoleWe are seeking an experienced Regulatory Affairs Director to join our team at Syneos Health. As a key member of our regulatory department, you will be responsible for planning and managing regulatory submissions in assigned regions/countries/projects.Key ResponsibilitiesContribute to the preparation of regulatory submissions, including IND,...

  • Clinical Regulatory Writing Consultant

    1 month ago

    Québec City, Canada Parexel Full time

    When our values align, there's no limit to what we can achieve.   Do you have a flair for Clinical Regulatory Writing? If you love writing, have a passion for clinical regulatory strategy, have experience with biologics, and are looking for an opportunity that will allow you to continue to have the flexibility of working from home while gaining...

  • Associate Director, Regulatory Affairs

    4 weeks ago

    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...

  • Associate Director, Regulatory Affairs

    4 weeks ago

    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...

  • Associate Director, Regulatory Affairs

    4 weeks ago

    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...

  • Mgr-sales

    5 months ago

    Quebec City, Canada Amex Full time

    **You Lead the Way. We’ve Got Your Back.** With the right backing, people and businesses have the power to progress in incredible ways. When you join Team Amex, you become part of a global and diverse community of colleagues with an unwavering commitment to back our customers, communities and each other. Here, you’ll learn and grow as we help you create...

  • Clinical Regulatory Writer

    3 weeks ago

    Québec City, Canada Parexel Full time

    When our values align, there's no limit to what we can achieve.   Do you have a flair for Clinical Regulatory Writing? If you love writing, have a passion for clinical regulatory strategy, have experience with biologics, and are looking for an opportunity that will allow you to continue to have the flexibility of working from home while gaining...

  • Regulatory Affairs Project Manager

    5 days ago

    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...

  • Automotive Consultant/trainer

    5 months ago

    Quebec City, Canada Safe-Guard Products International LLC Full time

    **Internal Job Title**: Regional Performance Manager - Bilingual (English/French) **Location**:Remote - Quebec **FLSA**: Exempt **Job Overview**: The Regional Performance Manager supports a major OEM auto maker relationship, the OEM’s retail dealerships, and related staff with Safe-Guard Product and Services Training and Sales Advisory Services. The...