US Regulatory Compliance & Operations Lead, CHC
Location: Bridgewater, NJ
Travel Expected: ~10%
Job Type: Full-time
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.
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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
Core leadership function to ensure regulatory compliance for our products with strong collaboration with Global Regulatory and our internal teams such as manufacturing & quality. Ensure compliance of our base business and also help define areas of focus for future regulations.
Position Responsibilities
- Review and provide guidance in the compilation of relevant regulatory documents planned for submission to assure that they are complete and accurate. Documentation may include FDA meeting requests, briefing packages, IND and NDA submissions, label changes, site changes, methods, manufacturing changes and annual reports. Track our plan for local & global brands in order to plan & manage resource.
- Compile information and documentation necessary for the submission of Annual Reports to ensure compliance work closely with site quality; ensure timely planning and submission.
- Ensure that regulatory projects are prioritized, and ensure that global & local requests are managed; act as point of contact for internal & external requests.
- Work closely with NA country quality to ensure that our team is audit ready and facilitate any inspection planning with the appropriate cross functional teams.
- Ensure compliance for National Drug Codes (NDC) and maintain NDC list.
- Management of drug listings each drug product
- Ensure that our Sales Department are supported as required with retailer requests on County of Origin, Country of Manufacture, Trade Agreements Act affidavits, CRP and TSCA status, "Made in the USA" determinations, etc.
- Manage and maintain cross portfolio projects including CPSC Child testing reports.
- Ensure regulatory expertise into simplification of our processes & workflows in areas such as MLR approval process within NA & Veeva Vault documentation working with global team as needed.
- Deliver special projects/other duties as assigned may include among other assignments including accountability for departmental coordination of critical activities, training & budget.
- Ensure strong collaboration & team work with site quality and country quality teams to ensure compliance. Support quality leads at Chattanooga site to ensure compliance in areas including Drug Enforcement Administration (DEA) and Pseudoephedrine (PSE) licenses & quota, State Boards' of Pharmacy licenses, establishment registrations, drug listings.
- Assist in and provide additional information for commercial invoices and other documents needed to import as required.
Job Requirements
Education
- B.S. required, M.S preferred.
Experience
- 5+ years regulated CHC industry experience across multiple regulatory classes (NDA, Monograph, Device, Cosmetic, Food, Dietary Supplement).
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
Pursue Progress, Discover Extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
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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.