Job Description
Director, Regulatory CMC Dublin pharma
With a management team that includes unique world class expertise in their clinical field, our client is a young exciting biopharmaceutical company focused on the discovery of solutions to a number of serious debilitating diseases. Rapid expansion has led to the need to create a key leadership role in their Dublin office.
Reporting to the Global Head of Regulatory Affairs, and according to the directives of the company leadership and management, and in accordance with current regulatory requirements, established procedures and the planned objectives, the CMC Regulatory Director will be responsible for supporting all CMC regulatory filing activities for various IMPDs, CTAs, pre-IND meetings, INDs, and MAAs/BLAs and tracking CMC regulatory commitments. Management and execution of these activities should be done in compliance with applicable current regulations and standards.
Responsibilities:
- Lead the planning, preparation and review of CMC regulatory filings, including but not limited to IMPDs/INDs, MAAs/BLAs, amendments, variations/supplements, agency briefing documents and responses to requests from regulatory agencies
- Develop EU/US CMC regulatory strategy and work with Global Head of Regulatory Affairs in support of a global regulatory strategy
- Manage customization of IMPD/IND dossiers, and work with Regulatory Affairs in the planning, submission and registration of drug products in a professional, compliant and timely manner
- Manage timelines in cooperation with Project Management, Regulatory Affairs, subject matter experts, CMOs and the CMC team to ensure timely regulatory submissions and meeting of all CMC regulatory commitments
- Support Regulatory Affairs, CMC and projects teams by providing CMC related regulatory guidance to achieve short-term and long-term goals on time and with highest quality
- Assist in review of change controls, including cross-checking the information in INDs/IMPDs, CTAs and BLAs/MAAs, and any other regulatory filings to ensure that CMC related changes are reported to competent authorities in accordance with regulatory requirements on a timely basis
- Establish, manage and maintain a knowledge base of current and emerging legislation and regulatory requirements and guidelines pertaining to CMC
- Work with cross-functional teams to resolve emerging issues related to manufacturing operations
- Participate in CMC project team meetings and provide current regulatory requirements that pertain to CMC activities
- Provide support to CMO sites in preparation for and during Pre-Approval Inspections, as required
Person Spec
Minimum of Bachelor’s degree in health science or medical field or equivalent
Minimum of 6-10 years of relevant CMC pharmaceutical industry experience with a focus on biologics
Knowledge of EU and US procedures
Pre- and Post-marketing/life-cycle management experience
Project management experience
Comprehensive knowledge of CMC Regulatory Affairs
Must be able to interact with CMOs and CMC team on a regular basis
Approximately 20 % travel required: U.S. and Europe
Excellent written and verbal communication skills
Ability to build/forge relationships with key parties
CV to gerry@rftgroup.ie