Regulatory Affairs Manager - CMC

☞ Proclinical Staffing

View: 152

Update day: 12-04-2024

Location: Basel Basel-Stadt BS

Category: Legal / Contracts

Industry: Medical Equipment Manufacturing Biotechnology Research Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Contract

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Job content

Proclinical are recruiting a Regulatory Affairs Manager - CMC for a pharmaceutical organisation. This role is on a contract basis and is located in Basel.Responsibilities
  • Offer regulatory assistance for projects and project teams.
  • Write, evaluate and offer contribution from a CMC perspective on pertinent documents necessary for clinical (IND/IMPD) and commercial (BLA/MAA) proposals for biologicals.
  • You will prepare and/or evaluate replies to agency proposal evaluation queries.
  • Enable and/or attend CMC meetings with crucial shareholders and regulators when suitable such as FDA/EMEA for biologicals.
  • The ideal candidate will attend customer meetings and project team meetings.
  • Responsible for preparing source documents for customer RoW proposals, which involves certifications and attestations where suitable.
  • Other duties may be assigned.
Key Skills And Requirements
  • Educated to a degree level in a life science field such as biology, biochemistry, pharmacy, or an advanced degree level.
  • At least 5 years of experience in preparing and writing CMC sectors for regulatory documents through product lifecycle.
  • Comprehension of regulatory needs for biologicals.
  • Familiarity with regulatory affairs within a pharmaceutical setting.
  • Acquaintance within a CMO/CDMO setting would be beneficial.
  • Abilities in handling priorities and project timelines.
  • An organised individual with a high attention to detail.
  • Fluency in the English and German languages.
  • Works well within a multifaceted matrix setting.
  • Interpersonal and communication skills.
  • Capable of staying calm while under pressure.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 0789542 or p.duvall@proclinical.com.Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.Proclinical Staffing is an equal opportunity employer.#Regulatory
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Deadline: 27-05-2024

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