Head of Regulatory Affairs
|Job Title:||Head of Regulatory Affairs|
|Contact Name:||Richard Williamson|
|Job Published:||July 31, 2017 08:59|
My client, an innovator pharmaceutical company are hiring for a Head of Regulatory Affairs to join their company in Berkshire, with the objective to assure that new products are developed in line with the global regulatory requirements of targeted countries, obtains expedient registration of these products in a cost effective, timely manner and maintains the registrations of existing products in compliance with applicable legislation.
- Develops regulatory strategies for development projects and manufacturing improvements, analyses risk vs. benefit in regulatory strategies to ensure successful review by regulatory authorities
- Negotiates submission data requirements and deliverable dates with regulatory authorities and internal technical teams. Authors, with other team members, key pieces of regulatory submissions
- Manages the preparation of registration dossiers and submission of Marketing Authorisation Applications in line with regulatory authority requirements and responses to deficiency letters in a timely manner. Liaises with licensing partners or affiliate companies to ensure submissions of MAAs in their territories can be successful
- Acts as a point person for regulatory agency interactions, including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, responses to agency letters pertaining to the assigned products/teams
- Manages the routine Marketing Authorisation maintenance activities CP/DCP/MRP/National including compilation and submission of variations and renewals. Manages distributors to ensure Marketing Authorisation compliance and to ensure timely submission of variations and renewals, including translations
- Evaluates manufacturing and labelling changes, liaising with other internal departments regarding implementation timelines, etc. Accurately describes these changes for ease of regulatory agency review
- Ensures new product artwork is generated in line with regulatory requirements and to agreed timescales. Manages the process for MA post-approval artwork amendments
- Ensures Manufacturer's / Importer's Authorisations and Wholesale Dealer's Licences are maintained in line with changing business requirements
- Responsible for regulatory compliance to include the raising of regulatory Change Controls and the maintenance of regulatory SOPs
- Evaluates promotional materials for regulatory impact and to ensure compliance with applicable regulations and Codes of Practice. Responsible for the Regulatory sign-off of Promotional Materials
- Ensures that product reference information, internal and external medical information databases and the company website are maintained in an up-to-date / compliant fashion from the regulatory perspective
- Maintains awareness of global regulatory legislation and assesses its impact on the business and product development programs.
- Supports the marketing, commercial and business development functions of the company with regard to the handling of enquiries and NPD project related activities (query management, product due diligence, dossier development, etc).
- To provide managerial support and training to employees by supervising staff, establishing employee goals that align with other business partners, maintaining job descriptions, creating employee development plans, providing performance feedback and recruiting and retaining staff members.
For more information on this exciting role, please call Richard Williamson on 02033273072 or apply to this advert.
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