Regulatory Affairs Manager
The Manager Regulatory Affairs is responsible for said portfolio of products in the applicable region(s). Responsible for authoring submissions for dissemination to Health Authorities, country distributors or external partners. Will work closely and train other junior regulatory staff as required and will review submissions compiled by other team members. Will represent Regulatory Affairs on cross-functional teams to ensure the business and its partners are aware of all regulatory requirements and meet pre-defined timelines.
- 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.
- Work closely with the team to ensure regulatory strategies are executed and submissions are sent to Health Authorities within required timeframes
- Maintain Current knowledge of EU & International regulation & guidances.
- 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.
- Work closely and train junior regulatory staff as required.
- 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).
- Significant Rest of the World experience
- Minimum of 5 years experience within Generics
- Previous managerial experience including remote management experience; mentoring junior staff and handling team members in various locations
- Knowledge of global regulatory filings
- Medical Device experience a plus
- 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
- Must have thorough understanding of technical and scientific information to advance project goals
- Requires a B.S. degree in Science or in related field
- Knowledge of EU & International regulatory requirement
- Controlled Substance regulatory requirement knowledge
- M.S. and /or RAC (preferred)