Regulatory Affairs Senior Manager APAC
A large biopharmaceutical company are looking for a talented Regulatory Affairs Senior Manager focused on the APAC (Asia Pacific) region join their team in Maidenhead. This organisation is known for their extensive experience in discovering and developing human therapeutics.
- Responsible for driving development and implementation of International Growth Markets (IGM) regulatory strategies for new product registrations and labelling lifecycle management activities in the Asia Pacific (APAC) region (supporting the Regional Lead).
- Member of regulatory project team(s) representing the IGM for 1-3 marketed products (acting as the Product Lead).
- Responsible for ensuring availability of contemporary regulatory documentation to support new submission and lifecycle management activities for specified marketed products (acting as the Product Lead).
- Provides regulatory support to IGM regional leads including submissions for NCE /NME.
- Responsibility for providing IGM strategic input for early development compound as a member of the regulatory project team (RPT)
- Accountable for the internal R&D IGM input on market needs/requirements, strategy development and communication for agreement with global asset teams
- The colleague will be solely accountable for delivery of regulatory strategy for new products, line extension and lifecycle management.
- The colleague will have full accountability for communication, development and delivery of regulatory strategies for their assigned products. They will work closely with all Regional Leads, including their direct line manager to deliver those strategies
Skills and Requirements
- Minimum 3-5+ years pharmaceutical/biotechnology industry experience in International/Regulatory Emerging Markets
- Experience and knowledge in the preparation of major regulatory submissions supportive amendments, supplements and labelling lifecycle management.
- Good knowledge and understanding of applicable regions.
- Demonstrate excellent communication skills.
- Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and supply chain colleagues.
- Demonstrate effective cross-cultural awareness and capabilities.
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall on 44 203 0789 542 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.