Associate Director, Regulatory Affairs, Labeling

Posted 08 Oct 2019

Billerica, Massachusetts - United States

Req Id 198725


A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

Your Role:

The Associate Director, Labeling role involves providing strategic regulatory expertise and labeling operational leadership to cross functional teams for successful development of regional labeling (US Prescribing Information [USPI] and EU Summary of Product Characteristics [SmPC]), target product labels and core data sheet (CDS) documents.


Responsibilities include:
•    Lead the development, review, approval, and implementation process for CDSs, USPIs, SmPCs and labeling documents in a cross functional environment.
•    Provides tactical guidance to product labeling review teams regarding label development and maintenance
•    Develop and implement regulatory labeling strategy and documentation for products in development
•    Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations by FDA
•    Participate in labeling negotiations with agencies resulting in product approvals or labeling updates; and release of labeling for use throughout the company. 
•    The position also includes assistance in training of new labeling managers and associates.    



Who You Are:

Minimum Qualifications:

•    Master’s degree in scientific or medically-related field 
•    Minimum of 5 years of experience in the pharmaceutical industry
•    Thorough knowledge of US and EU regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products.
•    Knowledge of labeling requirements in other regions.
•    Strong organizational skills and ability to network and coordinate discussions across all levels of the company to reach resolution on labeling topics.
•    Self-motivated, self-driven, problem solving skills, ability to adapt to different cultural and business environments     
•    Ability to travel internationally

Preferred Qualifications:

•    PhD in scientific or medically-related field
•    7+ years’ experience in the pharmaceutical industry



What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!


Curious? Apply and find more information at


The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.


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