Priya Mukherjee at CK Clinical is currently recruiting for a Regulatory Affairs Manager to join a successful pharmaceutical company based in London.
This is a fantastic opportunity to join a growing organisation at an exciting time of change and growth and to gain regulatory experience in a truly international environment.
Regulatory Affairs Manager Job Description:
As Regulatory Affairs Manager you will be handling international Regulatory Affairs maintenance work on licensed product(s) in close collaboration with local affiliate companies in multiple countries around the world (except the USA and Japan) . You will also play a lead role in planning, managing and executing regulatory activities on your assigned product(s) in the countries where they are approved. This will include submission of variations, renewals, line extensions, responses to authority requests and Marketing Authorisation applications.
Further responsibilities of this Regulatory Affairs Manager position will include:
- Plan, manage and execute regulatory activities on product(s) such as submission of variations, renewals, line extensions, responses to Authority requests, Marketing Authorisation Applications in further countries
- Drive submissions through the approval procedure (MRP, DCP, CP) in the EU
- Interface with regulatory counterparts in affiliate companies to support regulatory activities on assigned product(s)
- Plan and coordinate dossier preparation and review of submission documents
- Review of PSURs and coordination of PSUR submission
- Act as point contact for EU Regulatory Authorities, i.e. the Reference Member States for MRP/DCPs and the EMA
- Serve as the Regulatory Affairs representative in the Safety Management Team and other internal teams
- Regulatory assessment of change requests
- Handling of regulatory documents in the electronic data management system
- Handling of product-related data in the registration database
- Independently drive and complete assigned tasks
- Timely delivery of tasks / full ownership of assignments
- Provide training, coaching and/or mentoring to other Regulatory staff
- Comply with all applicable regulatory requirements and company standards and procedures
- Perform other duties as assigned
As Regulatory Affairs Manager you will have the following qualifications, skills and experience:
- A degree in pharmacy/life science discipline (OR Equivalent)
- Strong skills in written and verbal communication (in English)
- Proven European regulatory submissions capability, in particular in post authorisation activities
- Proven experience in interactions with European Regulatory Authorities in relation to all aspects of regulatory activities
- Proven experience working with CROs and external service providers Knowledge/Skills
- Detailed knowledge of EU regulations and guidelines, in particular on submissions post approval
- Knowledge of eCTD
- Good communication skills and ability to function well in an international/inter-cultural and team-oriented environment
- Computer skills
- Excellent organizational skills and flexibility
- Familiarity with electronic data management systems and registration databases
- Excellent project management and communication skills with the ability to engage effectively across different geographies, regulatory systems and organisations.
How to apply:
For more information or to apply for this Regulatory Affairs Manager position, please contact Priya Mukherjee at CK Clinical on +44(0)1438 870028 or email firstname.lastname@example.org.