Senior Manager, Global Regulatory Affairs U.S. Region

Posted 30 Apr 2019

Rockland, Massachusetts - United States

Req Id 191388

Details

 

A career with EMD Serono is an ongoing journey of discovery: our 51,000 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.

 


In this role as Senior Manager, Global Regulatory Affairs U.S. Region, you will be responsible for submission strategies and activities pertaining to lifecycle management and compliance for the U.S. This will include, but not limited to, Supplements, CBE-30, Annual Reports, in the disciplines of Administrative, Chemistry, Manufacturing and Controls (CMC), as well as Clinical (Labeling) changes. As Senior Manager, you will also partner with internal stakeholders as the Country Regulatory Affairs expert for your assigned marketed products. 

 

In This Role You Will:

  • Serve as the Country Regulatory Affairs representative for the U.S. at Global Regulatory Sub-teams for assigned marketed products
  • Collaborate and coordinate FDA interactions and submission activities with the Global Regulatory Affairs organization
  • Review and prepare regulatory documents (e.g. Meeting Requests, Briefing Documents, CMC and Labeling supplements, General Correspondence, Annual Reports and Periodic Safety Reports, etc.) for eCTD submission to the FDA in compliance with regulatory requirements and standards
  • Review Clinical Study protocols and publication manuscripts from the Regulatory perspective to support medical and commercial communications
  • Perform technical assessment of submission content against commitments, regulations, and guidance documents
  • Maintain appropriate documentation for FDA contacts and submissions according to SOPs
  • Work with internal Regulatory peers in the areas of Advertising and Promotion, Operations, and Compliance to ensure a holistic approach to product management
  • Update and maintain internal tracking databases for planning, scheduling, submissions, action dates, and overall project coordination and management
  • Agency liaison for NDA/BLA supplements, maintenance activities, and OPDP submissions, as required

 

Who you are: 

  • A BS/MS degree in Life Science or related discipline; Advanced degree such as PhD, and PharmD would be an asset
  • Postgraduate credentials and/or RAC certification in Regulatory Affairs is highly desired
  • Minimum of 6 years of industry experience of which at least 5 years have been in U.S. Regulatory Affairs and specifically in lifecycle management, maintenance, and compliance activities
  • Regulatory experience in the therapeutic areas of Oncology, Neurology, Fertility, and/or Endocrinology is highly desirable
  • Experience in submission preparation in accordance with ICH, eCTD, and US requirements
  • Experience with regulatory agency interactions and preparation of documents for regulatory agency interactions
  • Extensive working knowledge of Regulatory Affairs in the disciplines of CMC and Labeling
  • Working knowledge and experience in the review of Advertising and Promotion materials would be an asset
  • Excellent written and spoken communication skills in the English language
  • Good interpersonal skills
  • Attention to details, quality, and follow-through
  • Ability to collaboratively work in teams
  • Project management and organization skills
  • Strong business acumen
  • Ability to travel ~10% locally between Boston offices in Billerica and Rockland, MA, continental U.S., and globally

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 https://jobs.vibrantm.com

 



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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