Regulatory Expert - Pharma and Food Materials

Posted 15 Jan 2020

Burlington, Massachusetts - United States

Req Id 201803

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 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.


Your role:

You will act as a Regulatory Expert with a focus on single Use System (SUS) and Gene Therapies. In this function you will provide regulatory and scientific expertise to our customers and internal stakeholders globally. You guide peers, middle and upper management regarding regulatory issues and challenges within your discipline. You will be a key regulatory Subject Matter Expert (SME) overseeing global regulatory requirements relevant to SUS and Cell and Gene Therapies in conjunction with quality, the business and operations.

  • Ensure regulatory compliance of our products for Single Use Systems (SUS) and Cell and Gene Therapies with applicable regulations in North America, Europe and, in collaboration with regional organizations, Asia/Pacific, Latin America and EMEA.
  • Monitor, evaluate and interpret regulations that affect our business and our customers.
  • Prepare regulatory assessments and regulatory action plans in the product development process (PDP).
  • Provide input for or prepare customer facing statements for regulatory topics.
  • Represent our company by attending and speaking at regulatory events.
  • Represent our company in industry associations.
  • Develop relationships with key regulators in the USA and Europe.
  • Liaise with other internal departments on cross functional regulatory issues.

 

Who you are:

  • You have earned a graduate degree in natural science that provides knowledge of theories, principles and concepts applicable to Regulatory Affairs.
  • You have3 to 5 years of hands-on, quality and regulatory experience with Single Use Systems (SUS) and Cell and Gene Therapies or products for use in these and their manufacture.
  • You have excellent knowledge of relevant legal and regulatory requirements on a broad scope of regulations globally, including industry standards and authority landscape.
  • You have professional experience in relevant business associations in a regional and  global environment.

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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