Executive Director, Head of Global Labeling & Ad/Promo Regulatory

Company: Millipore Corporation
Location: Billerica
Posted on: January 13, 2021

Job Description:

Your role:--In this role you--provide strategic leadership and oversight to Labeling and--Ad/ Promo--activities, both in the US and abroad.--You will--manage a highly competent and technically skilled team, comprised of 20-25 internal and external resources, and--a functional budget of over $5 million.--Reporting to the Head of Global Regulatory Affairs,--you will work--closely with--key internal stakeholders including--commercial, medical affairs, legal and compliance, corporate affairs, and patient advocacy to ensure external product and disease state communications are both effective and compliant.--This position--ensures--delivery of innovative--and--quality--& compliant labeling of our products globally,--of compliant regulatory review of--Ad/ Promo--materials for--both--the US--and Global--markets,--and ensures--effective supplier management related to functional area sourced activities.?In this role--you will build--a strong leadership and functional capability to keep pace with the changing science and regulatory environment.--You will--establish an effective implementation and oversight model to maintain best in industry regulatory compliance as well as effective utilization of digital approaches and technologies to drive in-depth regulatory insights--for our--products.??? Who You Are: Required Qualifications:?? * You completed a--BS degree in life sciences or related scientific discipline * You gained--15+--years' experience in Regulatory Affairs (8+ in--US Ad/Promo--and labeling strategy), Nonclinical Research, or Clinical Research, specifically, in the submission of regulatory filings for drug/--biologic products.? * You possess working knowledge of FDA and--International--Biologics/--Drug regulations; experience with IND, CTA, BLA, NDA, MAA, eCTD, and 2253 regulatory submissions.? * You have proven experience in driving--change and innovation? * You--have the ability to--travel domestically and internationally Preferred Qualifications? * An advanced degree--(MS, JD, PharmD, PhD, etc.)? * Experience with combination (i.e., drug/device or biologic/device), biologics or drug products and oncology is preferred.?

Keywords: Millipore Corporation, Billerica , Executive Director, Head of Global Labeling & Ad/Promo Regulatory, Executive , Billerica, Massachusetts