US Regulatory Affairs Lead, OTC Brands

Location

Bridgewater, NJ | United States

Job description

Responsibilities

About Us

At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to drive what we believe is the next health revolution: evolving from simply serving consumers, to helping people help themselves - bringing “Health in Your Hands”.

Sanofi Consumer Healthcare US (formerly Chattem) is a leading marketer and manufacturer of a broad portfolio of branded over-the-counter (OTC) healthcare products, in such categories as allergy, upper and lower gastrointestinal, skin care, topical pain care, oral care and other OTC toiletry products.  The US CHC portfolio includes well-recognized brands such as: Allegra, Nasacort, Xyzal, Dulcolax, Gold Bond, Cortizone-10, Icy Hot, Aspercreme, ACT, Unisom, and Selsun Blue.

To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. We aspire to create a work environment where people can thrive, grow, and be at their best every day. We believe in operating with integrity and prioritizing the health and well-being of people and communities where we operate, working towards making a positive impact in the world.

Position Summary

• Provide strategic regulatory guidance and work in multi-disciplinary teams to identify innovative and sustainable new product opportunities, assist with the successful development and approval of new products and identify novel regulatory development pathways that will ultimately drive business growth.
• Proactively help to drive the CHC vision of self care by understanding the changing healthcare ecosystem and its impact on the product portfolio, , anticipating product vision adjustment needs driven by consumer involvement, and shaping the external regulatory environment.
• Develop effective regulatory strategies with cross-functional team support on both strategic and tactical product issues & opportunities including matters related to policy, product/project strategy, FDA submission, labeling and advertising.
• Works externally across US Trade Associations to identify and resolve regulatory issues and strategic CHC aligned opportunities to promote self-care
• Responsible for all regulatory decision making and problem solving needed to support the brand product portfolio.
• Develop the regulatory strategy and ensure effective execution for new innovative consumer-centric products and the life cycle management of products in the portfolio across any/all regulatory classes (NDA & OTC monograph drugs, dietary supplements, cosmetics, foods and medical devices).
• Responsible for regulatory approval and maintenance of all product claims compendia for the therapeutic category.
• Drive and develop the most effective regulatory strategy for the registration of NDAs and ANDAs, medical devices, combination medical device/OTC, dietary supplements, and OTC monograph drug products.
• Responsible for timely and effective communication with health authorities including the submission of highly ethical and scientifically robust documents, as well as the timely responses (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products.
• Ensure that all documents to be submitted to regulators represent the CHC aligned strategy, are complete, accurate, compliant with global and/or local submission standards and are organized in a manner to facilitate agency review..
• Provide the regulatory strategy and intelligence for due diligence and business development initiatives.
• Serve as an educational resource to both internal and external customers.
• As a leader, work with various regulatory personnel at all levels to support the business unit objectives.
• Work hand-in-hand with the Canadian Science Affairs team helping drive 1 team in North America.

Position Requirements

• The successful candidate will possess a strong track record demonstrating highly effective communication, negotiation and influencing skills that has proven impact on our brands and business.
• He/She will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision making working across global and regional teams.
• He/She will bring creative & innovative ideas to the table to support the CHC vision of serving healthier, fuller lives.
• He/She will be accountable for the regulatory leadership of OTC brands for NA and share leadership responsibility within the entire CHC Regulatory team which may involve working across categories.

Education

• B.S. required. M.S., Pharm D, MD, PhD preferred.
• Regulatory Certification (RAC) preferred.

Experience

• 8+ years of experience in Regulatory Affairs, including leadership roles.
• Established experience supporting NDA and OTC products.
• Deep knowledge of regulatory requirements to support OTC product development and life-cycle management Demonstrated success in developing regulatory strategies.
• Recognized strategic leadership and effective collaboration.

What's In It For You

• Competitive Pay
• Three (3) Weeks Paid Vacation
• Robust 401(k) + Employer Match
• Health, Dental, Vision Insurance
• Tuition Reimbursement
• Parental Leave
• Learning and Developmental Opportunities
• Employee Resource Groups

EEO/AA Employer: Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, or protected veteran status.

Location: Bridgewater, NJ, USA

Relocation: Relocation assistance is not available.

Travel: Minimal (about 10%).

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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