The purpose of the role:

This role requires the holder to demonstrate a high level of regulatory expertise in one or more global regions (e.g., US, Europe, Japan, Canada, Australia, Emerging Markets). The Regulatory Affairs Project Manager is a subject matter expert in multiple areas of regulatory operations and is expected to provide both technical and scientific guidance across all aspects of regulatory in order to facilitate generation of the highest quality regulatory documents for the client. Regulatory Affairs Project Manager is the primary operational contact for clients on regulatory submission content and quality so that client input is reflected as appropriate in the submission, and the submission format meets regulatory authorities' stated requirements. Working closely with the Account and/or Project Manager, they track and resolve all budget, time, resource, and contractual issues to ensure smooth project deployment and maintenance. Regulatory Affairs Project Manager must be prepared to assist the department by helping to define and achieve department goals. In addition to project management responsibilities including monitoring and reporting on execution of deliverables through all program/project phases, Regulatory Affairs Project Manager also has direct supervisory responsibilities. The Regulatory Affairs Project Manager creates, maintains and executes project plans by providing the necessary project leadership to ensure on-time deliverables various lifecycle maintenance submissions.

What will you do:

• Lead role in planning, executing and monitoring Regulatory Affairs and/or Regulatory Operation projects
• Ensure that the team follows, and strictly adheres to Standard Operating Procedures, Guidance Documents, Policies, and Project Standards throughout the duration of the project. Conduct performance reviews of team.
• Develop milestones and timelines and ensure that the team is successful in obtaining goals.
• Coordination and publishing of regulatory submissions for Investigational (IND, CTA) or Marketing Applications (e.g. MAA, NDA, NDS, 510k) to Global Health Authorities in eCTD, NeeS, or paper formats.
• Submission QC, resulting in a high quality final product.
• Records and tracks submission deliverables and other metrics in appropriate databases.
• Assure standards adhere to and/or client SOPs and guidance.
• Supervisory responsibility of junior regulatory affairs staff.
• Creation, maintenance and execution of project plans and regulatory strategy.
• Coordination and publishing of regulatory submissions to Global Health Authorities, also non-EU/US markets.
• Author, review and/or facilitate regulatory CMC documents for Health Authority submissions using or client agreed templates.
• Coordination of activities for marketed products, which may include but are not limited to license variations, renewals, annual reports and other amendments, ensuring that all submissions adhere to regulatory requirements.
• Completes accurate compliance assessments and offers resolutions to regulatory issues and Health Authority questions.
• Execute global and local labelling activities for established products.
• Coordinate CCDS/CCSI maintenance and labelling committee reviews.
• Author, review and/or facilitate regulatory labelling documents for Health Authority submissions using or client agreed templates.
• Dispatch, coordinate and maintain traceability of global labelling updates in local markets.
• Complete accurate compliance assessments and offers resolutions to regulatory issues and Health Authority questions.

What we expect:

• Bachelor’s degree in natural science, life sciences or pharmacy; advanced degree is preferred.
• Minimum 8 years’ experience in a Life Sciences industry with a minimum 5 years of experience in pharmaceutical regulatory affairs.
• Knowledge in handling registrations and maintenance of pharmaceutical, medical device, consumer and/or cosmetic products from a global, regional and local perspective.
• Excellent international regulatory understanding and experience in handling business process excellence.