Director, Regulatory Affairs Operations EMEA
Job Location: Windsor, Berkshire, England, United Kingdom
Job Code: F3446
Job Salary Package: Highly competitive salary, car, bonus and full benefits package
Celgene continue to grow their business and scale their regulatory resources. This appointment will be an important position in the European Regulatory Affairs management structure and will oversee a range of functions that contribute to the successful and sophisticated regulatory affairs activities throughout the region.
This job will require someone with a strong profile in operational and organisational leadership and management. The successful applicant with be able to demonstrate a clear stratregic vision and the capacity for driving forward the function to provide the optimal level of capability for Celgene as it continues to expand.
With the current portfolio of products and regulatory outlook, this is an extremely exciting role with tremendous scope.
The Job Description
Responsibilities will include, but are not limited to, the following:
1. Manage and Lead the EMEA region Regulatory Operations team, which supports submissions publishing, regulatory labeling, archiving, intelligence information and reports, databases, license tracking tools, intranet portal, and other activities as assigned.
2. Overall responsibility for regional regulatory operations strategy and goals, resource needs and allocation.
3. Hire, coach mentor and manage team, and ensure career development plans are in place for all staff, as assigned.
4. Develop and implement effective operations strategy and regional plans aligned to business and regulatory objectives.
5. Ensures regional compliance with SOPs and WPs. Supports or leads development of new SOPs, WPs, or best practices for regulatory operations either for regional needs or global regulatory.
6. Work with global regulatory operations colleagues to leverage benefits from common and consistent approaches to regulatory operations
7. Identify and analyse applicable industry technologies, standards and processes and propose changes accordingly, including budgetary needs. (e.g. eCTD, EDMS, PIM)
8. Identify issues that will impact programs and provide proactive strategies for dealing with them.
9. Working with Regulatory Product counterparts, oversee the preparation and production of Regulatory Submissions for EMEA region using internal & external resources.
10. May serve as a regulatory representative on cross-functional teams
11. Monitor and provide insight into new guidance relevant to regulatory operations
12. May participate in or lead industry associations and symposia in accordance with responsibilities (e.g. EFPIA, ICH, DIA)
Skills/Knowledge Required:
- Bachelor’s degree in appropriate discipline; Advanced degree preferred; Experience in Regulatory Operations and/or related areas.
- Extensive pharmaceutical industry experience, (to include significant experience in regulatory affairs or operations and exposure to oncology development). Experience working in a global company required.
- Thorough knowledge of the drug development process, European drug regulations, especially related to regulatory operations.
- Proven experience of managing and leading teams in an international organisation
- Inter-dependant partnering skills, team-orientated and demonstrated ability to influence outcomes are necessary skills in the environment.
- Good understanding of technologies as they relate to the effective management of the regulatory operations department
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Must be able to innovate, analyse and solve problems of complex nature with minimal supervision and with attention to detail
- EU and occasional
