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Associate Director Regulatory Affairs, Established Products Cambridge United Kingdom,
Mundipharma Research (company)
Posted on : 22 December 2017
- 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
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