Ensure regulatory compliance of drugs commercialized in the UK with the pharmaceutical and legal regulations in accordance with the company's specifications and the applicable relevant regulations, processes and standards.
The Regulatory Affairs Manager supports the local RA Lead in interactions with the MHRA.
Tasks And Responsibilities
- Regulatory submissions to national regulatory authorities as needed (e.g. CTAs, MAAs, line extensions, CMC changes, educational materials)
- Life cycle management activities of registered products, e.g. renewals, PSUR/DSUR submissions, post-authorization commitments
- Labeling changes, i.e. translation checking and implementation into national texts
- Updates of educational materials
- Updates of packaging materials
- Review of promotional and non-promotional materials
- Compliance with the Risk Management Plan (i.e. additional risk minimization measures)
- Maintenance of the regulatory quality management system (QMS), follow-up with Corrective Action Preventative Actions (CAPAs) and changes as well as the creation of new SOPs as necessary
- Oversight of local SOPs and work instructions, maintenance, and review of the local regulatory processes in alignment with global SOPs and policies.
Work experience
- Several years of experience in Regulatory Affairs within the pharmaceutical industry is required; biotech is a plus
- Working knowledge of the local Agency regulations and industry standards pertaining to regulatory is essential
- Knowledge in pharmacovigilance and quality management system is highly preferred.
- Experience on regulatory submissions including NDA, life cycle management and labeling.
- Good knowledge on local GMP guidelines and requirements, experience in GMP inspections is preferred.
- Proven track record of effective collaboration with local agency in gaining approvals and defending approved products.
- Strong knowledge of local regulatory environment and excellent understanding of all stages of drug development, including pre-approval and marketed compounds.
- Ability to build team relationship and collaborate in a global team environment at all levels of the organization.
- Strong interpersonal communication, organizational and leadership skills.
- Good English oral and written communication skills are required
- Ability to support projects to completion/ experience working in project teams
- Ability to work in a flexible environment to meet all regulatory requirements and business requirements
- Some travels required