Company: Planet Pharma Staffing Limited
Closing Date: 28 Oct 16
Salary (£): On Application
Planet Pharma are recruiting a (Senior) Manager of Regulatory Affairs on behalf of our client, an international Pharmaceutical Company in London
Role: (Senior) Manager, Regulatory Affairs – International Pharmaceutical Company
Location: London, UK
Job Type: Permanent
Planet Pharma are recruiting a (Senior) Manager of Regulatory Affairs on behalf of our client, an international Pharmaceutical Company in London. This is an exciting permanent opportunity for an experienced Regulatory professional looking to develop their career in an innovative and growing company!
The (Senior) Manager, Regulatory Affairs will provide EU Regulatory guidance, direction and support on submission strategy and planning to/on relevant project teams, working closely with Regulatory Project Leads and other project team members globally. With the prospect of both development and marketed products in the portfolio, the (Senior) Manager, Regulatory Affairs will be expected to apply their experience across a range of regulatory requirements throughout the European region.
- Actively participate in project team meetings; by applying regulatory knowledge and expertise, providing strategic input, regulatory support and guidance
- Support post-marketing licensing requirements and ensure effective liaison across the organisation to optimise regulatory strategy
- Manage the CTA submission process and ensure successful approval of CTA applications, define CTA strategies, including appropriate oversight and management of CRO vendors
- Lead responses to review queries from Health Authorities
- Assume ownership and responsibility for regulatory projects, working collaboratively with stakeholders internally and externally
- Liaise with functional groups in London/US/Asia and corporate partners related to clinical and post-marketing submission activities to obtain and/or provide information/data for regulatory submissions
- Ensure thorough technical review of regulatory documents for approval prior to submission to health authorities
- University degree in a Life Sciences subject
- Extensive experience in Regulatory Affairs within the pharmaceutical industry, with specific experience in the area of clinical submissions to Health Authorities
- Experience of post-marketing regulatory affairs, including variations and life cycle management, as well as European procedures (CP, DCP, MRP, PIPs)
- Experience of working in a cross-functional team
- Ability to work well within a matrix environment, build team relationships and interface in a global team environment at all levels of management
- Proven ability to plan, effectively coordinate and lead activities simultaneously on multiple projects, all with tight deadlines
- Good project management skills
- High attention to detail
- Fluency in English, both oral and written communications
10 Greycoat Place, London,
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