Sr. Manager, Regulatory Affairs – UK
Location: Maidenhead, England
Department: Regulatory EU
The Senior Manager, Regulatory Affairs is responsible for the implementation of Regulatory Affairs strategic imperatives including driving marketing authorisation applications, variations and post-approval submissions in Europe, with UK as a special area of responsibility.
This position contributes to the development, modification and execution of regulatory strategies and tactics. A key responsibility is to negotiate and influence regulatory authorities through regular contacts to improve regulatory outcomes. Additionally, this position will provide regulatory guidance for various cross-functional project teams and define, generate and review regulatory documents as well as advise on data requirements and analyses required in submissions.
- Negotiate with and influence regulatory authorities through regular contacts to improve regulatory outcomes and execute regulatory strategies
- Responsible for the development and review of various regulatory submission documents for Interaction with EMA, MHRA, and other regulatory agencies in support of labelling, clinical, quality, safety and commercial activities
- Collaborate with other functions including Product Development, Clinical Operations, Manufacturing and Quality to develop, coordinate and execute the regulatory strategies for new product development registrations.
- Responsible for the maintenance of the regulatory approvals including Paediatric Investigation Plans (PIPs), Orphan Designations, PRIME and Market Authorisation Applications (MAAs)
- Develop and implement regulatory strategies and workplans, including regulatory risk management, ensuring adherence to agreed timelines and schedules and that any RA issues are flagged and managed in a timely fashion.
- As subject matter expert, provide regulatory guidance as needed for the business, 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 labelingServe as a Regulatory representative on project teams, particularly for UK and other non-EU countries eg Switzerland
- 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
- Support the development and maintenance of the Regulatory Affairs working practices, SOP’s and procedures
- Uses appropriate IT and software tools to ensure the correct format and presentation of documents
- Other duties as assigned.
- PhD/PharmD with 3+ years’ experience in Regulatory Affairs or BS degree with ~7 years’ experience in regulatory affairs including regulatory oversight of clinical trials and experience of working with MHRA and EMA
- 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