Associate Director, Regulatory Affairs, Global Labeling Strategy Lead
Company: emd serono
Location: Billerica
Posted on: January 1, 2026
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Job Description:
Ready to explore, break barriers, and discover more? We know
you’ve got big plans – so do we! Our colleagues across the globe
love innovating with science and technology to enrich people’s
lives with our solutions in Healthcare, Life Science, and
Electronics. Together, we dream big and are passionate about caring
for our rich mix of people, customers, patients, and planet. Thats
why we are always looking for curious minds that see themselves
imagining the unimaginable with us. United As One for Patients, our
purpose in Healthcare is to help create, improve and prolong lives.
We develop medicines, intelligent devices and innovative
technologies in therapeutic areas such as Oncology, Neurology and
Fertility. Our teams work together across 6 continents with passion
and relentless curiosity in order to help patients at every stage
of life. Joining our Healthcare team is becoming part of a diverse,
inclusive and flexible working culture, presenting great
opportunities for personal development and career advancement
across the globe. This role does not offer sponsorship for work
authorization. External applicants must be eligible to work in the
US. Your Role: 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 companys 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 Key
responsibilities include: • 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. Who You
Are Minimum Qualifications: • 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 Preferred Qualifications: • 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 Pay range for this position: $132,700 -
199,100. The offer range represents the anticipated low and high
end of the base pay compensation for this position. The actual
compensation offered will be determined by factors such as
location, level of experience, education, skills, and other
job-related factors. Position may be eligible for sales or
performance-based bonuses. Benefits offered by the Company include
health insurance, paid time off (PTO), retirement contributions,
and other perquisites.
Keywords: emd serono, Hartford , Associate Director, Regulatory Affairs, Global Labeling Strategy Lead, Science, Research & Development , Billerica, Connecticut
