Regulatory Project Manager

Our client, a growing biotech organisation are currently recruiting for a Regulatory Project Manager to join their organisation on a permanent basis. As Regulatory Project Manager you will be responsible for the coordination and the day-to-day support of the regulatory affairs strategy and operational activities of the organisation. As Regulatory Project Manager you will provide support to both CMC, non-clinical, and clinical development.

Responsibilities

• Coordinate input from external regulatory affairs consultants, identify and close knowledge gaps
• Provide regulatory support to the Clinical Development Team (CDT) and CMC Project Team
• Handle Scheduled Drug Licenses for the project-related work, both for CMC and Clinical Development activities. This includes obtaining, documenting and storing of external parties’ licenses, supporting shipments of API and study drugs (import/export licenses), supporting clinical trial sites in getting relevant scheduled drug licenses, including the DEA licenses in the U.S
• Coordinate activities towards the U.S. FDA (IND, Agency meetings, annual reports, NDA) and EMA (CTAs, Scientific Advice, MAA) and expedited programs
• Develop and maintain effective working relationships with other CDT and CMC Project Team members
• Contributes to the development of the regulatory timelines, resources, budget, risk, and quality plans
• Accountable for meeting or exceeding goals for regulatory affairs operations for development projects
• Ensures all regulatory tracking needs are identified and facilitate reporting to the Senior Management team
• Ensure maintenance, tracking, and accuracy of regulatory data and milestones
• Develop or provide regulatory input to the development of CMC non-clinical and clinical study documents, including study protocols and reports, IMPD, and Investigator’s Brochure
• Keep up to date with local and international regulatory requirements
• Regularly communicates the regulatory activity status and timelines and escalates unresolved issues appropriately
• Contributes to responses to study questions or issues from Health Authorities or EC/IRBs, including adaptation of procedures towards the new EU CT Directive, as implemented

• University Degree related to Life Sciences (e.g., human biology, biochemistry, biology, pharmaceutical science, medical doctor, veterinary medicine, chemistry, engineer)
• Proven regulatory affairs experience in a consultancy, pharmaceutical and/or biotech company of at least 5 years, including:
  • Document owner of full or parts of Common Technical Dossiers (CTD)
  • Identification and selection of investigational sites, interactions with Principal Investigators and KOLs
  • Ethics Committee and Competent Authority submissions
  • Development of timelines, budgets and resource plans in complete and/or partially outsourced settings
  • Experience across a range of therapeutic areas, experience in psychiatry and/or neurology is a benefit
  • Experience of leading/overseeing external vendors (regulatory affairs consultants)
  • Solid experience with working in a regulated environment under GxP and with adherence to Company SOPs, policies and guidelines
  • Updated knowledge of ICH GxP requirements
  • Experience with regulatory support of development of scheduled drugs is a benefit
  • Experience with regulatory support of development of device development is a benefit
  • Experience with IND, NDA submissions in the U.S. and CTA/MAA submissions in Europe is a benefit

• Self-driven and motivated team player
• Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
• Excellent written and verbal interpersonal communication, influencing and customer care skills demonstrated by an ability to present clear instruction/direction to team members
• Good organization and tracking skills, as well as attention to detail
• Mandatory fluent English (both oral and written) – other languages are an asset