Regulatory Affairs Manager

vor 2 Wochen

Basel, Schweiz Proclinical Vollzeit

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.
- 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.

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.

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