Regulatory Affairs Lead

Accepting BioReady™: Yes
Category: Regulatory Affairs
Education: Bachelor
Experience: 4-6 Years
Employer: Sanofi
Location: Laval, QC
Posted: October 13, 2021
Closes: November 12, 2021

Job description:

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.     

Sanofi entities in Canada include Sanofi Genzyme (Specialty Care), Sanofi Pasteur (Vaccines), General Medicines and Consumer Healthcare. Together we employ approximately 2,000 people. In 2019, we invested $131 million R&D in Canada, creating jobs, business and opportunity throughout the country.

POSITION SUMMARY

Reporting to the Head Scientific Affairs CHC, the Regulatory Affairs Lead CHC is responsible and accountable for regulatory compliance activities that support new product development and products currently on the market that occur throughout the product lifecycle of Over-The-Counter (OTC) drug products, Natural Health Products (NPN), and Cosmetics.

In addition, the Regulatory Affairs Lead CHC also provides leadership to and along with Product Development and Commercial in identifying new product and claims opportunities, regulatory enabling opportunities, generate product evaluation summaries and novel regulatory development pathways that will ultimately drive business growth.

KEY DUTIES FOR THIS JOB

  • Identify and clearly communicate appropriate regulatory requirements per regulatory classifications (e.g. Division 1, Division 8, Natural Health Products (NHP), and Cosmetics to local and global teams throughout developmental, mature and life cycle product management (including possible Rx to OTC Switch).
  • Provides regulatory strategy (analysis and interpretation of regulations) and intelligence for due diligence and business development initiatives.
  • Ensures execution efforts and coordination of the preparation and on-time delivery of compliant submissions according to regulatory classification.
  • Leads agencies interactions (example Canadian Health Authorities, Ad Standards Canada) on both strategic and tactical product issues and opportunities including matters related to policy, product/project strategy, submission, labeling and advertising.
  • Proactively identify potential regulatory risks, recommend solutions and opportunities within defined scope of responsibility on the business in a timely manner to appropriate cross functional teams.
  • Supports the development of the strongest claims/advertising and promotion possible within the regulations, provide solution-oriented advice ensuring risks are appropriately addressed and communicated. Participate and validate the promotional and non-promotional materials to ensure full compliance with internal & external guidelines/standards.
  • Assess compliance of formula ingredients and final formulations in consideration of conditions of use. Proactively alerts business of any issues encountered and how to mitigate them.
  • Develop, review, and maintain product labels including product monographs products to ensure corporate and regulatory compliance through an End-To-End labeling process and this within established timelines.
  • Support Commercial teams in the launches’ activities.
  • Develop or maintain procedures and processes to ensure compliance with the Food & Drugs Act, Health Canada Regulations, and other applicable industry standards. Contributes and supports regulatory process improvement initiatives.
  • Develop, optimize, and maintain a network with key partners including the Canadian regulatory authority and key opinion leaders and seize opportunities to negotiate improved regulatory processes with the Canadian authority.
  • Represents Sanofi Consumer Health Inc. at the external Trade Association (example: Cosmetics Alliance Canada; Food, Health & Consumer Products of Canada).
  • Works within CHC and externally across Canadian Trade Associations to identify and solve for issues and strategic CHC aligned opportunities to promote self-care.
  • Monitors Canadian Regulatory activities and identifies emerging local and international (EU and US) regulations and/or changes to Regulations that impact Sanofi Consumer Health Inc. products. Communicates status and proactively develop plans and gains alignment internally to address any Regulatory change and how it should be managed.
  • Review and provide comments on Health Canada draft guidelines and policies.
  • Provide Regulatory input into Periodic Benefit Risk Evaluation Report (PBRERs)/ Periodic Safety Update Report (PSURs) if needed.

KEY REQUIREMENTS FOR THIS JOB

EDUCATION:

  • Minimum Bachelor of Science degree in Pharmacy, Pharmacology, Chemistry, Biological Sciences, or equivalent. Regulatory Affairs Certificate preferred.

EXPERIENCE:

  • At least 5 to 7 years of experience in regulatory affairs with 4 years in in Cosmetic, OTC drug, and NHP products regulatory affairs environment.

SPECIFIC SKILLS AND/OR COMPETENCIES

  • Knowledge and understanding of Canadian regulatory framework for OTC drug products, NHP, and Cosmetics products and promotional product claims
  • Knowledge and understanding of Canadian Medical Devices regulatory framework is an added asset.
  • Highly organized, rigorous work ethic
  • Excellent interpersonal skills
  • Ability to work effectively in cross-functional teams and be self-directed
  • Strategic agility
  • Excellent communication skills
  • Excellent negotiation skills
  • Strong Project Management, decision-making, and problem-solving Skills
  • Good risk analysis skills

LANGUAGES

  • French: Excellent oral and written communication skills
  • English level required: Advanced oral and written communication skills
  • MICROSOFT KNOWLEDGE
  • Knowledge of Microsoft Outlook, Microsoft Word, Microsoft Excel, and Microsoft PowerPoint
  • Knowledge of data sharing platform such as TEAMS or SharePoint

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

Thank you in advance for your interest.

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