This role will support the Head of Scientific Affairs with activities associated with the registration of human and veterinary product in worldwide markets including US, EU and Japan, as well as Regulatory Compliance liaison with QA for registered products. and to lead and develop the companies regulatory affairs team.
- Together with the Head of Scientific Affairs, actively plan regulatory requirements ensuring major milestone targets for each product are visible to all team members and key stakeholders to achieve on time market entry.
- Together with the Head of Scientific Affairs, determine tasks and resources required to deliver each project milestone and deliverable
- Work with the Clinical Affairs team to support clinical trials by direct responsibility for activities associated with the clinical trials including Regulatory approvals and IMP management.
- Oversee licence maintenance support to customers, Regulatory agents and internal departments
Regulatory Compliance liaison with QA
- Licensing Activities
- Manage licensing activities for existing marketing authorisation applications in Europe, US, Japan, Canada and various markets in South America, Asia and the Middle East
- Manage submissions to target markets, including liaison with R&D, QC, and Production as well as external experts where required
- Strategic planning of regulatory activities in target markets for company products
- Coaching/mentoring- support members of team with problem solving and skills development to aid learning and early problem resolution
- Minimum B.Sc. primary degree in Chemistry, Pharmacy or Pharmacology but any Science related discipline considered
- At least 10 years Regulatory affairs experience to include responsibilities in supervisory/people management
- Familiarity with cGMP in pharmaceutical manufacturing
- Significant experience of Regulatory Approval processes for pharmaceutical products globally
- Technical knowledge of analytical/ formulation development of pharmaceutical Products (e.g. solid oral dosage forms, biologics, fill finish, inhalations)
- People management/leadership skills
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.