Director, Product Regulatory Affairs - Pharma (Remote)

As a leader in the science of nutrition, Nestlé Health Science believes in empowering healthier lives for patients and consumers through a rich product portfolio featuring top brands such as Garden of Life®, Nature's Bounty®, Vital Proteins®, Nuun®, Persona Nutrition®, BOOST®, Carnation Breakfast Essentials®, Peptamen®, Compleat Organic Blends®, and more, as well as through Aimmune Therapeutics, a biopharmaceutical company developing therapies to prevent, manage and treat food, GI and metabolic-related diseases.

Our team members are challenged to make a genuine impact and play an integral role in driving the business forward. We embrace a dynamic culture that always puts the consumer first, and where ownership, accountability and agility are celebrated at every level. To help our people thrive, we offer expansive career growth potential, the opportunity to work alongside and learn from talented colleagues with diverse backgrounds and skill sets, and a range of best-in-class benefits.

We have more than 11,000 employees around the world, and products available in over 140 countries.

This position is not eligible for Visa Sponsorship.

The Director, Regulatory Affairs provides key support to the North American and global Regulatory Affairs teams. This position has primary responsibility for providing input into and managing regulatory documents for review and submission to North American regulatory agencies and other regulatory agencies (as requested). The position will oversee Regulatory budgets, CMC, and Labeling activities, identify, select, and manage internal/external subject matter experts and key opinion leaders as need be to support submissions of the highest quality for INDs, BLAs, NDA/S global marketing applications, briefing packages, annual reports, safety reports, amendments, and supplements.

Specific Responsibilities:

• In partnership with the VP, US Regulatory Affairs participate in the planning, development, and execution of regulatory strategies for document development, registration, and post-marketing/authorization activities to support, including but not limited to initial BLAs/Marketing Authorization (MA) applications, INDs/CTAs, annual reports, briefing books, Scientific Advice requests, IND/CTA/BLA/MA amendments, and other relevant regulatory filings.
• Oversee registration lifecycle maintenance submissions (BLA/IND) for existing product applications, including CMC and clinical aspects of the product portfolio.
• Assist regulatory management and subject matter experts in briefing documents generation and coordination of responses to requests or questions from regulatory authorities.
• Lead collaboration cross-functional team meetings to facilitate documentation requirements for submissions, compliance with regulatory guidance, and regulatory strategies execution within agreed timelines. In addition, communicate any identified risks and develop alternative strategies.
• Manage the preparation of regulatory submissions (author and review) to regulatory authorities and perform QC and approval of regulatory documents and submissions on assigned projects in compliance with applicable health authorities' guidelines.
• From a Regulatory perspective, support post approval commercial activities, as required.
• Engage with EU Regulatory Affairs colleagues to ensure an integrated, global approach to regulatory affairs activities.

Requirements and Skills:

• Bachelors degree in science with 10 -12 years broad professional experience gained from previous Regulatory Affairs roles
• Demonstrated, hands-on experience leading, managing, and preparing regulatory submissions
• Strong competence in understanding and applying regulatory requirements in a rapidly changing regulatory landscape
• Knowledge and understanding of US and ex-US regulations
• Experience and knowledge in the preparation of electronic submission
• RAC preferred
• Experience with FDA, Health Canada, and European regulatory requirements and guidelines
• Previous experience with BLA/NDA and IND/CTA filing and maintenance for new active substances

It is our business imperative to remain a very inclusive workplace.

To our veterans and separated service members, youre at the forefront of our minds as we recruit top talent to join Nestlé. The skills youve gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role. In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities. Nestlé seeks such skilled and qualified individuals to share our mission where you'll join a cohort of others who have chosen to call Nestlé home.

The Nestlé Companies are an equal employment opportunity and affirmative action employer seeking diversity in qualified applicants for employment. All applicants will receive consideration for employment without regard to race, ethnicity, color, gender, gender identity, age, religion, national origin, ancestry, disability, perceived disability, medical condition, genetic information, veteran status, sexual orientation, or any other protected status, as defined by applicable law. Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you may require any special accommodations in order to participate fully in our recruitment experience.

This position is not eligible for Visa Sponsorship.