Director, Regulatory Advertising and Promotion at EMD Serono, Inc. | Boston, MA | $211K/yr – $316K/yr

EMD Serono, Inc.

Director, Regulatory Advertising and Promotion

Boston, MA (Hybrid)

$211K/yr – $316K/yrDirector/Executive8+ years expFull time

Posted 5 weeks ago

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Job Summary

Own the U.S. promotional regulatory footprint for assigned products, shaping strategy, reviews, and FDA interaction to ensure compliant promotion and labeling across development and launches.

Own and lead cross-functional regulatory strategy and reviews for promo materials and claims.
Liaise with FDA OPDP/APLB and lead Promotional Review Committees to move submissions and inquiries.
Build and scale training, processes, and governance to sustain regulatory compliance.

Job Description

Responsibilities

Own U.S. promotional regulatory lead for assigned products, overseeing review, approval, and strategy.
Provide independent regulatory counsel to cross-functional teams ensuring FDA compliance.
Lead Promotional Review Committees and liaison with OPDP and APLB.
Manage complex inquiries and submissions including advisory comments.
Propose compliant strategies for complex promotional concepts.
Oversee regulatory positioning of product claims and ISI/Brief Summary as applicable.
Drive promotion processes, standards, and SOPs; promote continuous improvement.
Monitor regulatory trends and advise teams on guidance and enforcement.
Align labeling and global regulatory discussions with development; respond to FDA action letters.
Lead enterprise-wide training on promotional requirements and coach new hires.
Collaborate with Marketing, Legal, Medical Affairs, Quality; enable compliant execution.
Partner with Quality on audits and CAPAs; provide leadership for compliance improvements.
Act as subject matter expert and coach for new hires.

Requirements

Bachelor’s degree in a science or health-related discipline; advanced degree strongly preferred.
8+ years of pharmaceutical industry experience, with 5+ years as a primary reviewer of advertising and promotional materials.
In-depth knowledge of FDA regulations governing promotion, including OPDP and APLB processes.
Demonstrated ability to identify and deliver solutions to complex promotional regulatory challenges.
Strong diplomacy, interpersonal, and negotiation skills with a track record as a consensus builder.

Preferred

Experience leading or supporting drug promotion activities and product launches.
Understanding of regulatory landscape for prescription drugs, including labeling strategy.
Experience leading enterprise-wide training and fostering a culture of compliance.
Excellent verbal and written communication translating regulatory concepts for diverse audiences.

Benefits

Health insurance, paid time off, retirement contributions, and other perquisites.

EMD Serono, Inc.

We aspire to create, improve and prolong life for people living with difficult-to-treat conditions like infertility, multiple sclerosis and cancer. We are imagining the future of healthcare by working to translate the discovery of molecules into potentially meaningful outcomes for people with serious unmet medical needs. EMD Serono is the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada. Our global roots go back more than 350 years. Today, we have approximately 1,100 employees around the US with commercial, clinical and research operations in Massachusetts.Community Guidelines: https://bit.ly/2nbPYl1

Founded in 1981

Boston, Massachusetts, USA

1.8K employees (107 in marketing)

www.emdserono.com