Location: Greater London
Salary: Highly competitive + benefits
employment: full time, permanent
CPL Life Sciences are collaborating with a global anesthetic company that is 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 compliance, registration, and life cycle maintenance.
- Responsible for reviewing all submissions compiled by other team members prior to dissemination to Health Authorities, country distributors, or external partners.
- Collaborate with cross-functional teams to ensure PCC and its partners are aware of all regulatory 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 a 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 the 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 a related field
- Knowledge of EU & International regulatory requirement
- 8- 10 Years of relevant regulatory Exp. (Global Exp. Including EU & Major Rest of the World Markets) Preferred
- Must have worked in Generic company for at least 5 years
- Must have experience mentoring junior staff and handling team members in different locations/time zone.
- Must have a 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 the 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.