Senior Regulatory Affairs Manager, Pharma North America – Plainsboro, NJ

Senior Regulatory Affairs Manager, Pharma North America

Location: Plainsboro, NJ

Hybrid

As Senior Regulatory Affairs Manager, Pharma within the North America region, you will be part of a cross-functional team, based in Plainsboro, NJ. The activities linked to the position are highly complex due to the dynamics of the North American market and changing regulatory environments. Your responsibility will encompass the integration of the Marketing and Sales plans into your regulatory strategy program and its global roll out in cooperation with the regional teams. You will be part of a highly professional and motivated team.

We harness our natural curiosity and innovation expertise to deliver proven nutritional solutions that lead to better, healthier lives. This takes more than ingredients; it takes a partner. Come join our team and help us to bring progress to life.

At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work, benefiting to our People, Customers & Communities and driving business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated.

Your key responsibilities

• Lead the joint efforts for the development of the North American region to obtain market clearance for the Health Nutrition & Care portfolio, specializing in the Pharma and Medical Nutrition portfolios
• Direct and Manage product safety dossier preparation for product approval in collaboration with R&D, product and project management, and regional regulatory affairs teams. Coordinate the submission of dossiers to the regional authorities and follow up on the approval process.
• Work with global regulatory colleagues and North American business leaders to align on business priorities and objectives for the Pharma portfolio.
• Keep up to date and manage all Active Pharmaceutical Ingredients (API) drug master files with the US FDA. Ensure API products in the portfolio are registered with the US FDA National Drug Code directory and kept up to date. Manage FDA API import reporting.
• Develop regulatory assessments for product portfolio specifically for nutritional products and APIs. Support NA customer queries related to products and sites in close cooperation with internal functions.
• Participate actively in industry associations to support dsm-firmenich products and business interests.

This role is included in the Hybrid Work Model, spending 2 days per week in the Plainsboro, NJ office with the balance of the work week at a home-based office that is commutable to the site. Plainsboro, NJ is the preferred location for this role; however, a remote location in the eastern or central times zones will be considered. 

We bring

• A rich history and a promising future of bold scientific innovation and passionate creation with our customers
• A space to grow by encouraging and supporting curiosity and an open mindset
• A culture that prioritizes safety and well-being, both physically and mentally
• The opportunity to work for a company where sustainability is much more than a claim and is core to our strategy and purpose
• A flexible work environment that empowers people to take accountability for their work and own the outcome

You bring

• Minimum 10 years’ experience in Regulatory Affairs in relation to Pharma, vitamins and/or nutritional products required
• In depth understanding of US FDA, Health Canada, Canadian Food Inspection Agency regulatory requirements (Pharma, Generally Recognized As Safe, New Dietary Ingredients, Novel Foods)
• Regulatory experience with pharmaceuticals and/or APIs required and in-depth interdisciplinary knowledge in the areas of analytics, chemistry Biology and Toxicology
• Ability to influence as well as balance and reconcile different opinions
• Strategic and solutions-oriented approach
• Bachelor’s degree required; master’s degree in science (Food Chemistry, Food Technology, Food Engineering, Pharmaceutical Sciences or Natural Sciences; Public Health & Life Sciences) strongly preferred

Our recruitment process

Interested in this position? Please apply online by uploading your resume in English via our career portal by April 15, 2024.

About dsm-firmenich

As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life™ every day, everywhere, for billions of people.

www.dsm-firmenich.com

dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drives unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate: there’s a place for everyone at dsm-firmenich.

dsm-firmenich is an Equal Opportunity and Affirmative Action Employer. dsm-firmenich people are as diverse as our customers. For us that includes a commitment to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant’s race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.

We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable sharing this, please let us know.

Agency Note

Please note this is a direct search led by dsm-firmenich. We only accept applications from candidates, not from agencies nor subject to agency’s fees, percentages or similar. 

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