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Senior Regulatory Expert f/m

Votre rôle:

Ensure regulatory consultancy and regulatory compliance to support customer projects all along process development of biotechnology products up to commercial.

 Activities:

To give support and consulting advise to customers on Biotech Active Substance strategy for development from pre-clinical to commercial to comply with regulations.

To ensure regulatory compliance on site versus international guidelines and submitted files (review of internal documentation and Change process)

To elaborate regulatory documentation (CMC, regulatory assessment and regulatory answers)

To participate upon request to meeting with Regulatory Authorities

Regulatory watch

Qui vous âtes:


- More than 10 years experience in regulatory compliance and regulatory technical writing
- More than 5 years experience in Biotech processes
- Good communication and convincing skills
- English fluent
Mobility Travel 5%

Job Requisition ID:  194234
Location:  Aquitaine - all
Career Level:  E - Professional (10+ 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.


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