Regulatory Affairs, CMC Director
Our client is a major multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research. This Dublin based role requires an experienced Regulatory Affairs CMC professional for a permanent appointment.
The function of a (Sr.) Director Regulatory Affairs - CMC is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.
The individual has division and corporate level influence and is generally considered a key opinion leader and an expert resource both within the company and externally. The individual may influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and acts as an advisor/liaison to senior management in order to plan, evaluate and recommend Regulatory-CMC strategy. Develop and advance the organizations policy and procedures for Regulatory Affairs - CMC and compliance to establish a compliant culture
- Participate in developing/updating organizational code of ethics
- Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle
- Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions
- Develop global Regulatory-CMC strategies and update based upon regulatory changes
- Strategize Regulatory-CMC due diligence for potential and new acquisitions and advise executive management
- Sets quality and accuracy standards
- Anticipate emerging issues and develop solutions to them
- Develop solutions to address issues with other members of management and stakeholders
- Integrate Regulatory-CMC considerations into the corporation’s global product entry and exit strategy
- Recruit, develop, manage and mentor regulatory professionals to contribute to organizational/human capital planning
- Provide strategic guidance for resource and development planning
- Participate in applicable trade association/industry working groups to influence policy/rule-making in alignment with business strategies
- Communicate application progress to internal stakeholders
- Negotiate with regulatory authorities during the development and review process to ensure submission approval
- Provide strategic input and technical guidance on regulatory requirements to corporate and/or management stakeholders
- Ensure preapproval compliance activities are completed
- Formulate company procedures to respond to regulatory authority queries
- Ensure annual licenses, registrations, listings and patent information are maintained
- Develop CMC regulatory strategies which maximize opportunity to receive first pass approval of regulatory submissions
Bachelor''s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
10 years of experience in Regulatory-CMC preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.