Senior Managers, Global Regulatory Affairs

Posted 02 May 2019

Rockland, Massachusetts - United States

Req Id 191778

Details

A career with MilliporeSigma 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. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
 


Senior Managers, Global Regulatory Affairs

 

Job location: EMD Serono Research & Development Institute, Inc., 1 Technology Place, Rockland, MA 02370

 

Send resumes to EMD Serono Research & Development Institute, Inc., 400 Summit Drive, Burlington, MA 01803

 

Responsibilities:

 

The Senior Managers, Global Regulatory Affairs will be responsible for the following job duties:

 

  1. Serve as the Regulatory Agency liaison for all devices and pharmaceutical products submissions and maintenance activities;
  2. Collaborate internally by performing global development functions which include enhancing our business development functions and growing our portfolio in the United States, Europe, Japan, and China;
  3. Collaborate externally with local regulatory affairs of affiliates as well as with other pharmaceutical companies;
  4. Serve as our Regulatory Project Team Member for life cycle management projects;
  5. Prepare regulatory documents and regulatory strategies;
  6. Review of protocols and regulatory documentation; and
  7. Act as agency liaison for submission and maintenance activities.

 

Travel requirement: 10% international and domestic.

 

This position is eligible for the EMD Serono Research & Development Institute, Inc. Employee Referral Program.

 

Education and Experience Requirements:

 

Employer requires a Bachelor’s degree in Pharmacy or a closely related field and at least three (3) years of work experience in Regulatory Affairs for pharmaceutical products and medical devices.

 

In addition, the employer requires the candidate to have the following:

 

  1. Demonstrated knowledge of international regulatory affairs in a multinational company;
  2. Demonstrated ability handling submissions and interactions with international regulatory bodies;
  3. Demonstrated knowledge of drug delivery systems;
  4. Demonstrated ability preparing and writing regulatory documentation to support agency interactions; and
  5. Demonstrated knowledge of life cycle management including development and preparation of regulatory strategies.

 

All years of work experience can be gained concurrently.


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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