Regulatory Affairs Manager
Vor 4 Tagen
Proclinical are working alongside a pharmaceutical organisation who are recruiting for an individual to join their team. This role is on a contract basis. The opening position is for a Regulatory Affairs Manager. For more information, please get in touch now
**Responsibilities**:
- Conduct regulatory evaluations for aberrations and change control.
- Assist with site-specific regulatory documentation and actions.
- Uphold transparency of information across the regulatory function.
- Enable and/or attend CMC meetings with crucial shareholders and regulators when suitable for biologicals such as FDA, EMA, etc.
- You will prepare source papers such as facility and equipment appendices for customer RoW proposals, which involves certifications and attestations where suitable.
- Produce and uphold the company's drug master files where suitable for site actions.
- Other duties may be assigned to this role.
**Key Skills and Requirements**:
- Educated to a degree level in a lice science discipline, such as biology, biochemistry, pharmacy, etc.
- At least 5 years of experience in planning and writing CMC sections for regulatory papers through product lifecycle.
- Comprehension of regulatory needs for biologicals.
- Familiarity with regulatory affairs within a pharmaceutical setting.
- Acquaintance with CMO/CDMO setting would be beneficial for the role.
- Capable of handling priorities and project timelines.
- An organised individual with a high attention to detail.
- Fluency in the English language with knowledge in German which would be ideal.
- Able to work across a multifaceted matrix setting.
- Ability to work across a complex matrix environment
- Works well 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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