SRG are recruiting on behalf of a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team and are looking to recruit...
My client, an expanding Clinical Research Organisation are currently seeking to recruit a Senior Director of Regulatory Affairs to join their Regulatory team. This position plays a key role in the clinical trial management process. The role will be based from any of my client's offices across the UK.
This position is will lead the Regulatory Affairs team and is accountable for the development and implementation of the regulatory strategy for specific Sponsor projects, for ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the team. The RAD possesses strategic leadership skills, has deep experience in regulatory science and overall drug/biologic development processes and strategies. Experience and knowledge of therapeutic areas and drug development is an important enabler to being able to influence cross-functional discussions Sponsors and relevant stakeholders.
- Accountable for the development and implementation, at a regional or global level, of the regulatory strategy for a product/ group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the Sponsor;
- Leads and develops a regional and/or global regulatory strategy that is reflective of applicable domestic and international requirement;
- Conducts assessments such as regulatory gap analyses, considerations and strategy, risk planning and mitigation;
- Lead the development and implementation of innovative strategies to maximize the likelihood of regulatory success;
- Accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures;
- Accountable for post-market application maintenance and compliance activities;
- Partner with department staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally;
- Lead the regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality;
- Ensure effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements;
- Leads regulatory strategic development, communication and updates and ensures appropriate consultation and peer review;
- Monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise teams and department staff accordingly
- Provide regulatory leadership as needed in early development and due diligence review projects;
- Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project;
- Collaborate with US regulatory to develop global approval strategies
- Provide regulatory advice and guidance to project teams to ensure submissions meet regulatory requirements;
- Supervise, develop, and mentor regulatory personnel
- Advanced degree required. Preferred degrees include, PharmD, MD, and/or PhD. Other degrees and backgrounds may be considered;
- Extensive experience or equivalent of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more therapeutic areas;
- Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions (e.g. EMA, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.);
- Proven leadership and program management experience; including managing at Director level.
- Ability to think strategically and critically evaluate risks to regulatory activities;
- Ability to work strategically within a complex, business critical and high profile development program;
- Successful contribution to a major regulatory approval at a global or regional level
- If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Neal.Panting@SRG.co.uk or +441753 589626