Associate Director/Director Regulatory Affairs, Strategy - United Kingdom
- Develop and lead regulatory strategies and initial registration plans for development and approval of specific products for Europe, Japan, China and Australia US and Canada as required
- Provide regulatory advice and expertise to R&D and commercial project team counterparts.
- Contribute to the development of people and foster Mundipharma’s core values through mentoring, coaching and acting as a role model for all staff in regulatory affairs.
As Soon As Possible
Provide regulatory expertise to optimise drug developments and initial drug registration and approval strategies on assigned projects:
- Serve as the Regulatory Affairs lead representative on the product development Asset Team
- Provide regulatory expertise on current drug development and marketing authorisations requirements and procedures to develop faster to market product development and approval strategies with optimal labelling.
- Lead the development of the Strategic Regulatory Plan for the assigned project(s) including assessment of the probability of regulatory success together with risk mitigation measures and deliver regulatory milestones in accordance with the Plan
- Ensure the delivery of high quality submissions (CTA/IND, MAA/NDA, orphan drug designation, scientific advice applications) in a timely manner
- Initiate and manage appropriate responses to agency review issues, ensuring efficient review and approval of submissions within assigned timelines
- Maintain awareness of emerging regulatory and scientific guidance on general and specific topics of relevance to the therapeutic area and their impact on current Mundipharma product development plans
- Undertake due diligence activities as requested by the co-ordinating Head of Regulatory Strategy and provide critical regulatory assessment and recommendations to enable Mundipharma’s decision making process
- Contribute to the strategic drug development regulatory teams, improving quality of regulatory strategies, planning and promoting the function as a whole
- Represent Mundipharma regulatory affairs department at relevant external meetings, including global regulatory agency meetings, scientific and HTA advisory boards and trade association meetings. Use knowledge in regulatory affairs and standing in the regulatory community to influence widely Mundipharma’s ability to undertake drug development and product registrations
- Take ownership of individual objectives, and be accountable in achieving results while embracing Mundipharma core values. Facilitate teamwork, undertake mentoring and provide guidance to team members as needed
Qualifications & Experience
- Science degree or equivalent qualification: e.g. chemical and physical sciences, pharmacy, biochemistry, medical chemistry, biomedical science; or HND or equivalent industry experience where appropriate with extensive regulatory/clinical experience working in research-based drug development role
- Extensive regulatory experience in the biotech/pharmaceutical industry with a broad, in-depth knowledge and experience of drug development and approval requirements, preferably in pain or CNS therapeutic areas
- A track record of overseeing a substantial number and quality of drug development submissions and approvals, including CTA/INDs and MAA/NDAs working with or from within health authorities such as EMA, FDA, BfArM, MHRA, TGA, PMDA and others
- Proven ability to manage complex projects
Personal & Leadership Characteristics
- A strong strategic regulatory mind-set and demonstrated ability in representing the company to various regulatory health authorities in both diplomatic and persuasive ways
- Ability to build relationships and inspire confidence and respect at all levels; excellent team player
- Outstanding communication skills; ability to build rapport and demonstrate strong influencing and negotiation skills; excellent listening ability – receptive to feedback and demonstrates flexibility, curiosity and an ability to learn
- Consistently demonstrates and encourages others to adhere to the Company’s Core Values Honesty, Respect, Passion, Innovation and Commitment.
|Adress:||Mundipharma Research Limited |
Cambridge Science Park