The position will oversee and direct regulatory activities for all current products and the development of new projects. This may include regulatory support for disciplines such as clinical and preclinical development. The Director will maintain compliance with applicable regulations and provides guidance throughout the development and distribution of product lines. Relevant regulatory agencies include the US FDA, EMA, as well as other developing country regulatory agencies. The Director will be company representative and manage all aspects of US and International audits by notified bodies.
Candidates must have minimum 10 years of experience within Regulatory and a minimum 3 years as a Regulatory Manager/Director.
Candidates must be able to demonstrate knowledge and experience to perform the following duties:
- Develop regulatory strategies for the regulated products to ensure compliance with regulations and marketability/accessibility of the products
- Serve as the lead Regulatory Affairs department representative on project teams as assigned and advocate the regulatory scientific perspective
- Assist with developing strategies for various clinical trial phases. Provide technical assistance and expert oversight for the development of regulatory strategies related to collection, annotation, storage, and profiling of products
- Review, analyze, and translate regulatory requirements into a workable deliverable for project team meetings, executive management decisions, etc.
- Supervise, interact with and/or coordinate with staff and external service providers to ensure adequacy of project team support and deliverables
- Direct the planning and preparation of US and International regulatory submissions and/or prepare such submissions as necessary
- Conduct scientific and regulatory research and compile information in order to write, edit, and review reports
- Review regulatory documents and packets for submissions to national regulatory authorities (NRAs) and/or scientific or executive management boards
- Serve as lead writer for high priority submissions such as 510(k) and other regulatory submissions
- Lead internal preparation for key regulatory meetings and manage meeting logistics, eg, rehearsals, slide presentation, and preparation of sponsor minutes.
- Facilitate product registration and approvals
- Act as liaison with appropriate regulatory authorities
- Keep abreast of new regulations, standards, policies, etc issued by regulatory authorities
Perform other duties as assigned.
Candidates for this position should possess the following experience, knowledge, skills and abilities:
- 10 years of related experience, (3) three years supervisory experience preferred.
- Experience with Regulatory policy and procedure development.
- Experience with QSR regulated environment.
- Successful drafting and issuance of a 510(k).
- Domestic and international regulatory compliance and submission/approvals experience.
- Creative, constructive, responsive approaches to multiple expected and unanticipated challenges of complex regulatory filings with several national regulatory authorities.
- Demonstrated ability to orchestrate complex relationships among organizations and individuals and to interact effectively with regulatory agencies, clinical investigators and site staff, clients, colleagues, supervisors, subordinates, and the public.
- Excellent organizational, planning, negotiating, and problem-solving skills.
- Clear, concise, effective verbal (technical and interpersonal) and written (administrative and technical) communication and interpersonal skills.
- Ability to juggle multiple priorities and adapt to changing needs.
- Expertise and ability to make appropriate GMP compliance decisions independently.
- Represent the Senior Director of QA in compliance issues when necessary
- Attention to detail
- Computer literate
- Strong self-management skills with a high level of initiative, creativity, and assertiveness.
- Flexible, adaptable, and tolerant of some ambiguity; and capable of working well under pressure.