Associate Director Regulatory Affairs, Established Products - United Kingdom
- Develop and lead regulatory strategies for Mundipharma established products across all therapeutic areas.
- Provide regulatory advice and expertise to the Independent Associated Companies and commercial Established Brands team.
- 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
A. Specific Duties & Responsibilities
- Provide regulatory expertise to optimise maintenance activities and geographical expansion strategies on assigned projects
- Work collaboratively with outsource partners to ensure efficient and timely provision of regulatory services to the Independent Associated Companies to maintain and expand the established product portfolio.
- Plan, coordinate and prepare MA Applications for submission to fulfil commercial expansion plans.
- Manage the maintenance of MAs via renewals and variations.
- Coordinate and respond to questions from Regulatory Agencies during MA applications, MA renewals and variations.
- Provide pharmaceutical, preclinical, clinical and other technical information to our Independent Associated Companies and Licensees, to assist with the registration and maintenance activities of existing MAs.
- Plan and coordinate responses to regulatory questions relating to the group of Independent Associated companies’ products.
- Advise junior staff on data requirements for their activities.
- Be aware of and keep up to date with current legislation appropriate to Regulatory Affairs and provide expert advice on items or issues which will affect Regulatory teams.
- Take a high degree of personal responsibility for representing the Department both internally and externally.
- Take a high degree of personal responsibility for decision making and problem solving.
- Provide expert advice on items or issues which affect the Company.
- Participate in project teams and provide guidance in areas of expertise for marketed products.
- Ensure, where appropriate, that the electronic document management system is used for all submission documents.
- Maintain records of tasks, activities and registered product information in the internal regulatory databases.
- 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 experience working including MA maintenance / lifecycle management.
· Extensive regulatory experience in the generic or similar industry with a broad, knowledge and experience of world-wide MA maintenance / lifecycle management requirements.
· A track record of overseeing a substantial number post-approval products including geographical expansions into MEA, APAC and LATAM.
· Proven ability to manage complex projects.
Personal & Leadership Characteristics
· A strong strategic regulatory mind-set and demonstrated ability in developing regulatory strategy in line with commercial goals.
· 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.
This role will offer you the opportunity for personal development and will strengthen and enhance your scientific knowledge and understanding
|Adress:||Mundipharma Research Ltd |
Cambridge Science Park