Director of Regulatory Affairs Cmc

vor 1 Tag

Basel, Schweiz Proclinical Vollzeit

Proclinical are recruiting a Director of Regulatory Affairs CMC - CDMO Switzerland for a pharmaceutical consultancy. This role is on a permanent basis and is located in Basel.

**Responsibilities**:

- Lead the system owners through the issuance, proposal and upkeep of all regulatory documents such as DMF's, CMC documentations for INDs, IMPDs, NDAs, MAAs, etc.
- Offer assistance in the execution and implementation of the company standard at the respective sites.
- Serve as a SME in audits and inspections and chair the company RAC organisation as part of the corporate Quality Organisation.
- Guarantee that the internal standard within the regulatory compliance upkeep of the regulated products under consideration of customer needs.
- You will uphold CGAM owned registration files and assist customers in preserving the files, which might include the post approval change management.
- Assume responsibility for process ownership of the RAC chapter within the corporate management handbook, outlining and uphold the harmonised RA standard.
- Other duties may be assigned to this role.

**Key Skills and Requirements**:

- Educated to an advanced degree level in a chemistry, pharmacy or similar discipline.
- Know-how of RAC such as drug substances and/or drug product or CMC development.
- Expertise on GMP.
- Prior involvement in e-CTD systems.
- At least 5 years of experience working within a RA division such as drug substances or drug products.
- At least 5 years of experience either working or in a management role within a RA/GMP setting.
- At least 5 years of experience handling authorities and customers as well as experience in a leadership or consultancy role.
- Intercultural skills.
- Communication skills both verbally and in writing.
- Fluency in the English language.
- A flexible working mindset.
- Leadership abilities with the capacity to make solid decisions.
- Customer focused attitude.

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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