Overview Base location: London, UKRegion covered: Europe
We are seeking an experienced Regulatory Affairs Manager to join our client; a specialty, European Pharmaceutical Company dedicated to the treatment of CNS disorders.
The main purpose of this role is to lead the local provision and coordination of Regulatory Affairs services in our client and to closely coordinate activities with partners and contracted-out Regulatory Affairs providers within our client's geographic region.
- To be the Subject Matter Expert on Regulatory Affairs
- Develop and effectively execute regulatory strategies/plans in line with company expectations and required timelines
- To seek at all times to optimize label text, so that it best reflects the clinical utility and value that our client's brands offer, in line with the evidence base of the product
- To ensure that our client meets obligations and commitments to competent authorities at all times.
- Prepare regulatory submissions for new products, variations, and product changes, (including via DCP, MRP, National or Centralised Procedures) as required across multiple European countries, to ensure timely approval for market release
- Communicate directly with regulatory agency personnel (e.g. MHRA, EMA etc.) where required. Takes the lead and/or participates in meetings with regulatory agency personnel
- Provide support to Product and Manufacturing changes as necessary. This requires development of regulatory strategies, creating and submitting change notifications to regulatory agencies, updating technical files and design dossiers
- Take the lead on dossier preparation (and other materials such as briefing books for agency meetings, slide decks, question responses etc.) and publishing submissions working with appropriate vendors as required
- Take the lead in identifying/raising deviations, change controls, CAPAs etc. from a regulatory perspective and collaborate with other to effectively complete and follow up in line with agreed timescales. Review change controls, CAPAs etc. raised by others as a subject matter expert in regulatory.
- Good understanding of EU/MHRA regulatory procedures – essential.
- Experience of drafting Regulatory CMC variations – essential.
- Experience of participating in interactions with Regulatory Agencies – essential, experience in leading these interactions preferred.
- Previous experience within a similar environment would be an advantage.
- Computer literate (Microsoft Office including Outlook) and has a desire to improve
- Must be organised and able to prioritise well.
- Should be a self-starter, be proactive, determined and resourceful
- Has strong communication skills both written and verbal
- Understands the importance of compliance and acts with the highest standards