Associate Dir, Reg Affairs, Global Labeling Strategy Lead

EMD Serono Research & Development Institute•Billerica, MA

44d•Hybrid

About The Position

As an Associate Director, Global Labeling Strategy Lead, you play a key role in ensuring the safe and effective use of EMD Serono products which meet the company's strategic objectives. You lead the creation and maintenance of Company Core Data Sheets (CCDS), regional labeling documents including US/EU product information (PIs), and global packaging text in compliance with regulatory standards. You support country regulatory affairs in creating local PIs, ensuring consistency with the CCDS or a reference label. You serve as the subject matter expert on labeling-related health authority queries and may also work on target product labeling content for development products. Location: Preferred location in Billerica, MA - hybrid schedule

Requirements

Bachelor’s degree in science or health-related discipline
5+ years of relevant pharmaceutical industry experience with 3+ years of relevant Regulatory Affairs Labeling experience
Deep knowledge and application of labeling requirements in the US/EU
Advanced proficiency with MS Office (Word, Excel, PowerPoint, Project), SharePoint and regulatory systems (e.g., EDMS)
Meticulous in reviewing regulatory documents for accuracy, consistency, and compliance
Excellent written and oral communication skills

Nice To Haves

Advanced degree (PhD, MD, MS, PharmD, MBA)
10+ years of relevant pharmaceutical industry experience with 5+ years of relevant Regulatory Affairs Labeling experience
Knowledge and application of labeling requirements in global countries including Japan and China
Knowledge of global drug‐development and life‐cycle management regulations

Responsibilities

Create and maintain global CCDS in collaboration with product teams to serve as the basis for worldwide harmonized labeling. In some cases, maintain RSI to represent company position.
Manage the creation and maintenance, review and approval of US and EU PIs ensuring consistency with the CCDS.
Lead cross-functional labeling team, prepare for and present proposals to the Labeling Senior Management Board, and secure internal approval of labeling content.
Oversee and support implementation of CCDS content into local PIs.
Coordinate and respond to labeling inquiries from health authorities and participate in regulatory negotiations.
Lead the development of target product labeling content for development products, as needed.
Provide competitive labeling analyses and maintain up-to-date knowledge of local and regional labeling requirements.
Develop/contribute to labeling-related process documents and guidelines, propose company comments on regulatory initiatives, and drive cross-functional labeling initiatives.
Train product labeling teams on labeling processes, guide other labeling experts on life-cycle management, and cultivate relationships with regulatory professionals, associations, and authorities.