Manager Regulatory Compliance Program Jobs in Rochester, MI

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager to join our Regulatory Affairs Advertising and Promotion team. In this role, you will apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). This individual will provides regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs, Advertising and Promotion Director. The Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) and ensure that messages are translated into advertising and promotion initiatives that meet the commercial team's objectives, while maintaining the necessary state of compliance and corporate integrity.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Work Location: Sleepy Hollow, NY or Warren, NJ

• 4 days per week on site

Discover your role:

• Management of US regulatory activities associated with advertising and promotion of the company's marketed products. Manages commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director.

• Creatively contribute to the advise on the development of product messages and materials across multiple functional areas.

• Provide timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs

• Provide review of US and Global (if applicable) product and disease statematerials/communications,with guidance from Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance.

• Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.

• Responsible for establishing working relationship and managing communication with regulatory advertising and promotion professionals at co-promote partner companies

• Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions.

• Responsible for compliance with promotional material submissions to FDA on Form 2253

• Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications

• Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; in partnership with management, provide guidance to stakeholders with respect to impact of enforcement activities on the company policies.

• Ability to identify process improvement for promotional review activities that would enable the establishment of portfolio wide standardization of policies

• Ability to cross train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders

• Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports

• With guidance from management, help provide input during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities

• Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

This role requires:

• A minimum of 2 total years relevant experience, preferably within Regulatory Advertising and Promotion

• At minimum, a Bachelor's degree (BS) from an accredited college or university in Life Sciences. An Advanced Scientific degree (i.e., Masters, PharmD, Ph.D) is preferred.

• Knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion

• Experience with pharmaceutical products required, biologics experience is a plus

• Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred

• Ability to review promotional materials and interact with FDA OPDP/APLB and support launch products/campaigns, while maintaining excellent written/verbal communication skill when giving strategic regulatory advice

• Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations is desirable

• Contributes to the influence of cross-functional teams and may interact with senior management

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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)