Reference Number: JO-2011-457683
Regulatory Affairs Manager
Job Type: Permanent
Role: Regulatory Affairs Manager
Location: Greater London
Salary: Highly competitive + benefits
employment: full time, permanent
CPL Life Sciences are collaborating with a global anaesthetic company who are motivated to save lives with critical care solutions. In this role you will be responsible for authoring submissions for dissemination to Health Authorities, country distributors or external partners. Adding to that, you will be responsible for training junior regulatory staff as required and will review submissions compiled by other team members.
Other duties will include:
Interpret regulations, guidelines, and compliance requirements and communicate them to other team members and departments within the organization while demonstrating a high ability to make appropriate decisions.
Responsible for the development of Global, Regional and local (MENA/Gulf/LATAM/APAC etc) strategy aligning to the business needs for different projects
Work closely with the team to ensure regulatory strategies are executed and submissions are sent to Health Authorities within required timeframes
Manage the assembly, compilation and submission of documentation for product compli-ance, registration and life cycle maintenance.
Responsible for reviewing all submissions compiled by other team members prior to dissemi-nation to Health Authorities, country distributors or external partners.
Collaborate with cross-functional teams to ensure PCC and its partners are aware of all regu-latory requirements and meet pre-defined submission timelines.
Work with cross functional team and contract manufacturers to ensure successful and timely transfer of products to new CMO.
Manage a team of 3 including one-line manager
Effectively multi-task and establish priorities while working in a fast-paced environment.
Work closely with internal and external manufacturing sites to support the change control process and provide timely and accurate regulatory assessments for products in applicable region(s).
Create/revise SOPs and work instructions as necessary (including global harmonization of SOPs).
Requires a B.S. degree in Science or in related field
Knowledge of EU & International regulatory requirement
8- 10 Years relevant regulatory Exp. (Global Exp. Including EU & Major Rest of the World Mar-kets) Preferred
Must have worked in Generic company for at least 5 years
Must have experience mentoring junior staff and handling team members in different loca-tion/time zone.
Must have thorough understanding of technical and scientific information to advance project goals
Previously managerial experience preferred.
Knowledge of global regulatory filings preferred.
Must effectively multi-task, establish priorities and work in a fast-paced environment.
Must demonstrate leadership skills and ability to interact with management.
Possess excellent written and verbal communication abilities.
Expert knowledge of the pharmaceutical business and proficiency at interpreting regulatory guidelines to convey regulatory options while supporting strategic business objectives.
If you would like to apply for this position, please contact Amani via email@example.com . If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*