Regulatory Affairs Manager
vor 3 Stunden
Proclinical are recruiting a Regulatory Affairs Manager (LSW) - RZ for a pharmaceutical establishment. This role is on a contract basis and is located in Zug with hybrid working available. The client is focused on supplying novel solutions for various illnesses.
**Responsibilities**:
- Accountable for upkeep of product technical files and for current actions linked to compliance with international regulatory directives and guidelines.
- Handle the production and evaluation of SOPs and policy regulations for the regulatory affairs division.
- You might offer consultative and training assistance to the business unit and core regulatory staff connected to premarket proposals, product labelling and multifaceted proposals concerns.
- When suitable, you will interface with regulatory authorities on regulatory and technical issues.
- Other duties may be assigned to this role.
**Key Skills and Requirements**:
- Educated to a degree level in a science, engineering or similar discipline.
- A certification in regulatory affairs would be ideal.
- At least 3-5 years of experience in a regulatory, development, clinical affairs, quality, or program management role within an IVD, medical device, or pharma organisation.
- Familiarity with regulatory proposals which involves IDE, 510(k), and PMA proposals would be ideal.
- Past involvement in CDx with proposals for IND, NDA/BLA or pharma.
- An organised individual with a high attention to detail.
- Communication skills both verbally and in writing.
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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