My client, a Global Pharmaceutical Company, has opened a new vacancy within their Regulatory team and are actively looking to recruit a Regulatory Affairs...
My client, a Global Pharmaceutical Company, has opened a new vacancy within their Regulatory team and are actively looking to recruit a Regulatory Affairs Senior Manager. The role will be based at my client's offices in Central London.
The Regulatory Affairs Snr Manager will be responsible for all aspects of regulatory affairs in the EU and selected other non-US markets for products in the International Respiratory Group with a strong focus on leading and managing the development and implementation of regulatory strategy for new drug applications and life cycle maintenance of registered drugs in the Cystic Fibrosis Therapy Group, to include significant interaction with regulatory authorities.
- As part of cross-functional submission teams, responsible for the preparation, submission and management of technically complex regulatory submissions for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Applications include MAAs, new indications, variations, PIPs, Orphan applications, PSURs, DSURs, renewals and CTA applications.
- To provide appropriate strategic regulatory advice to Submission and Project Teams.
- To act as primary Company contact with Regulatory Authorities in the management of complex negotiations with Regulatory Authorities.
- To leading small sub-teams for the preparation of submissions.
- To plan, schedule and arrange own work activities with limited direction from a senior Regulatory Affairs professional.
- To manage interactions with local CROs/distributors.
- To maintain knowledge of regulatory requirements and to assess and communicate changes in regulatory information to project teams and senior management in a timely manner.
- To contribute to local and / or global company process improvements.
- To ensure all work is compliant with regulatory requirements.
Skills and Experience required:
- BSc. Advanced scientific related degree preferred;
- Strong experience within EU Regulatory Affairs.
- Experience in preparation and submission of documentation for Global agencies; MAAs, new indications, variations, PIPs, Orphan applications, PSURs, DSURs, renewals and CTA applications
- Demonstrates effective, self-sufficient communication skills, especially in peer-directed presentations.
- Displays sound project management skills.
- Exercises good judgment within defined procedures and practices to determine viable solutions
- Demonstrates advanced knowledge and understanding of applicable regulations.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.