Executive Director, Head of Global Labeling & Ad/Promo Regulatory
Company: Millipore Corporation
Location: Billerica
Posted on: January 13, 2021
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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
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