Sr. Manager, Regulatory Affairs – EU
Location: Maidenhead, England
Department: Regulatory EU
The Senior Manager, Regulatory Affairs, Europe provides assistance with marketing authorisation applications, variations and post-approval submissions in Europe, with UK as a special area of responsibility.
The Senior Manager supports the creation of regulatory strategies and tactics and defines, writes and reviews regulatory documents, and advises on data requirements and analyses required in submissions.
- Provide strategic and operational regulatory leadership to the development, commercialisation and life cycle management of assigned product(s)
- Negotiate with and influence regulatory authorities through regular contacts to improve regulatory outcomes
- Develop and review regulatory submission documents for Interaction with EMA, MHRA, and other regulatory agencies in support of labelling, clinical, quality, safety and commercial activities
- Maintain regulatory approvals including Paediatric Investigation Plans (PIPs), Orphan Designations, PRIME and Market Authorisation Applications (MAAs)
- Serve as a Regulatory representative on project teams, particularly for UK and other non-EU countries eg Switzerland
- Provide regulatory guidance, and present issues back to RA accordingly
- Accountable for the delivery of all regulatory milestones including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations
- Lead preparation of the regulatory strategy document and target product labeling
- Support regulatory affairs management in ensuring departmental awareness and compliance of current local, national, regional and harmonised guidance and requirements for the format, content, and control of all types of regulatory procedures and submissions
- Facilitate project team meetings for allocated programs
- Contribute to the development and maintenance of the Regulatory Affairs working practices and procedures
- Uses appropriate IT and software tools to ensure the correct format and presentation of documents
- Other duties as assigned.
Education and Experience
- BS degree
- 7+ years of experience in regulatory affairs including regulatory oversight of clinical trials and experience of working with MHRA and EMA
Knowledge, skills and abilities:
- Possesses a thorough knowledge of current UK and EU regulations and guidance of requirements for marketing authorisation applications through the UK and EU centralised procedure, variations and post-approval submissions
- Knowledge of regulatory requirements for medicines to treat rare diseases would be an advantage.
- Attention to detail, and ability to lead projects
- Excellent scientific writing skills for developing regulatory documents
- Excellent verbal and presentation skills
- Must be a demonstrated self-starter and team player with strong interpersonal skills. Must be a hands-on player with a global and patient-centric mindset
- Ability to embrace values of collaboration, excellence, compassion and courage