Regulatory Affairs Manager - EMEA

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.
• The ideal candidate will prepare, arrange and evaluate the authoring, binding, and proposal of registration application materials, specifically M1 to guarantee the smooth progression of review and approval procedures in a timely manner.

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.
• Acquaintance with registration procedures, such as formation / evaluation / proposal of MA applications, variations/supplements of post-approval management, etc.
• 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.

If you are having difficulty in applying or if you have any questions, please contact Evelyn Li at e.li@proclinical.com.

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.

#Regulatory