Sr Manager Regulatory Affairs - Labeling, Advertising and Promotions (Remote)

Nestl Health Science Job Opportunity

At Nestl Health Science, we believe that nutrition, science, and wellness must merge, not collide. Here, we embrace the intrinsic connections of these three pillars, harnessing their collective strength to empower healthier lives. Our broad product portfolio includes renowned brands like Garden of Life, Nature's Bounty, Vital Proteins, Orgain, Nuun, BOOST, Carnation Breakfast Essentials, Peptamen, Compleat Organic Blends, and more. We also have extensive pharmaceutical expertise, offering innovative medicines that aim to prevent, manage, and treat gastrointestinal and metabolic-related diseases. At Nestl Health Science, we bring our best for better lives. Our people are challenged to bring fresh, diverse views and make bold moves to empower healthier lives through nutrition. We know brilliant ideas can come from anyone, anywhere. Here we embrace the entrepreneurial spirit and collaborate with teams that champion focused and forward thinking. We are committed to fostering professional growth and celebrating the achievements of our people along the way. We offer dynamic career paths, robust development, opportunities to learn from talented colleagues around the globe, and benefits that support physical, financial, and emotional wellbeing. Join us to innovate for impact and reimagine the future of health and nutrition for patients and consumers.

Position Summary

Reporting to the Head of Global Regulatory Affairs Pharma, the Regulatory Affairs Advertising, Promotion, and Labeling Lead will be responsible for managing regulatory strategy and material approvals within their areas of responsibility, ensuring alignment with the overall company strategy. In collaboration with Global Regulatory Affairs leads and cross functional teams, this individual will develop and implement regulatory strategies for labeling, advertising, and promotion. They will ensure regulatory compliance, provide strategic regulatory guidance, and support product launches and commercialization throughout the product lifecycle in assigned territories. A key aspect of this role is fostering strong coordination and collaboration across internal departments and stakeholders, including Marketing, Technical Operations, Legal, Clinical, Commercial, Medical Affairs, Pharmacovigilance, and Compliance teams.

Key Responsibilities

• Guide, direct and coordinate the strategic labeling / advertising / promotion and planning for company products from a regulatory perspective for pre and post launch campaigns including strategic label development from target product profile (TPP), company core data sheet (CCDS) end to end development and maintenance
• Maintain oversight and efficiency of Veeva promotional, label systems for managing review and approval of labeling and advertising / promotional materials.
• Lead and manage periodic meetings, metrics for labelling charter. Provide input into or develop required processes, including transitioning of acquired products into company systems and associated standard operating procedures to ensure consistency of approach and regulatory compliance for areas of responsibility.
• This position has responsibility for overseeing staff, coordinating with cross functional teams in assembling regulatory documents such as pre-IND, IND and efficacy supplements by clearly articulating key regulatory considerations for review and submission to Competent Health Authorities and other regulatory agencies (as requested).
• Organize cross functional team meetings on management of change controls, labeling supplements and implementation of new / changes to approved product labels, prescribing information, medication guides, patient information leaflets and carton / container artworks
• Direct point of contact and signatory for FDA APLB (Advertising Promotion Labeling Branch) submissions and advisory comments for all BLAs (Biological License Applications) and commercial products

Experience and Education Requirements

Bachelor's degree in science with 10+ years of broad professional experience gained from previous Regulatory Affairs roles. Regulatory affairs certified (RAC) preferred. Demonstrated, hands-on experience leading, managing, and preparing regulatory submissions and knowledge in the preparation of electronic submission. Experience in reviewing and approving change controls, advertising and promotion as well as non-promotional materials within a complex specialty / branded commercial pharmaceutical organization. Preferred candidates will have experience in critically reviewing and implementing collaborative solutions to diverse promotional and MRL scenarios. Good interpersonal skills as well as a sound strategic business perspective with appropriate consideration to risk is required to ensure that effective regulatory and compliance practices are fully integrated into all associated development and post-marketing activities. Strong understanding of the global pharmaceutical drug development and regulatory environment, particularly in North America. In-depth understanding of the product commercialization and labeling development process is desired.

The approximate pay range for this position is $160,000.00 to $200,000.00. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities as well as geographic location. Nestl offers performance-based incentives and a competitive total rewards package, which includes a 401k with company match, healthcare coverage and a broad range of other benefits. Incentives and / or benefit packages may vary depending on the position.

It is our business imperative to remain a very inclusive workplace. To our veterans and separated service members, you're at the forefront of our minds as we recruit top talent to join Nestl. The skills you've 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. Nestl seeks such skilled and qualified individuals to share our mission where you'll join a cohort of others who have chosen to call Nestl home. The Nestl Companies are equal employment opportunity employers. All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status or any other characteristic protected 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. Contact us at accommodations@nestle.com or please dial 711 and provide this number to the operator : 1-800-321-6467. This position is not eligible for Visa Sponsorship. Review our applicant privacy notice before applying at . Job Requisition : 374482