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Regulatory Expert - Pharma and Food Materials

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.
Job Requisition ID:  201803
Location:  Burlington
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
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.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Nearest Major Market: Boston

Job Segment: Pharmaceutical, Medical, Product Development, Healthcare, Research

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