Regulatory Affairs Manager

vor 2 Wochen

Basel, Schweiz ProClinical Vollzeit

**Salary**:
Highly Competitive

Job type:
PermanentDiscipline:
Project Manager**Location**:
Switzerland- Basel, Schweiz
- Posting date: 27 Feb 2024

Reference:
57992

Proclinical are recruiting for a Regulatory Affairs Manager - EMEA to join a pharmaceutical organisation. This role is on a permanent basis and is located within the EMEA with the ability to either work remotely or on a hybrid basis.

Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.

**Responsibilities**:

- Accountable for new proposals of marketing authorisations, and post-approval regulatory upkeep such as renewals, CMC variations, safety information updates, PSUR/RMP reporting, review of change control requests, etc.
- Responsible for all regulatory affair actions for launched portfolios/products within designated countries or region(s).
- You will arrange and assist the corporate regulatory affair team within the international growth of the recognised markets with actions which involves offering leadership and knowledge.
- Form a reliable registration plan and be accountable for adaptation of documents and compilation of the regulatory report to comply with local authority needs.
- Serve as the main point of contact for all shareholders, engage with local regulatory agencies/external partners as regulatory representative for the allocated region.
- Responsible for setting up a local SOP system for product registration procedure and market access linked assessments to serve a long-term foundation for business operations.

**Key Skills and Requirements**:

- Educated to degree level in a scientific, life science, pharmacy or similar discipline.
- Familiarity with therapeutic areas, for example: oncology, cardiovascular, metabolism and the central nervous system would be ideal.
- Demonstrable experience within regulatory affairs in pharmaceutical organisations, with expertise in local PV and quality which would be beneficial.
- Expertise on FDA, EMA, and ICH guidelines with comprehension within regional legislation, policies, processes and respective regulations.
- An organised individual with the capability to drive the regulatory procedure with a sense of urgency.
- Communication skills both verbally and in writing.
- Works well with others both internally and externally, such as CMO, CRO, etc.
- Fluency in both Arabic and English would be ideal.
- Prior involvement working within a multinational pharma from Asia would be advantageous.

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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