Job ID: 137773281
10 - 15 years
The Vice President, Regulatory Affairs is responsible for providing global strategic and operational leadership for the planning, management, support and execution of regulatory activities, with emphasis on US, EU and Asia, across all indications associated with gemcabene. The incumbent is also responsible for ensuring that regulatory strategies are executed in compliance with current, applicable regulations and standards.
The incumbent works cross-functionally with internal departments, clinical, manufacturing and commercial, and external resources on Regulatory Affairs related issues.
The Vice President, Regulatory Affairs is accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. The VP, Regulatory Affairs will also have responsibility for reviewing and developing new SOPs as necessary.
- Develops and leads the global implementation of regulatory strategies for gemcabene throughout all stages of clinical and commercial development as well as CMC activities to support clinical development and commercialization.
- Collaborates with project teams and other internal and external key stakeholders as appropriate to ensure the effective registration for gemcabene while also supporting Gemphire’s clinical development, manufacturing and commercial/business objectives.
- Provides regulatory support for country-specific Early Access Programs (EAPs). This may also include assistance with the preparation of supportive regulatory documents for these programs.
- Serves as a primary liaison to US FDA, EMA and other key market Health Authorities.
- Defines strategies for, coordinates the execution of, and ensures the proper archival of regulatory submissions including, but not limited to: clinical trial applications; Marketing Authorization Approvals (MAAs) including those required to maintain approvals (i.e. variations, renewals) and customized dossiers for the registration of assigned products in a compliant and timely manner.
- Provides regulatory support to the Global Pharmacovigilance (PV) and regional/country representatives as necessary to ensure that Gemphire’s PV obligations are met.
- Contributes to the organizational design of the regulatory affairs function and plays a lead role in the selection of resources (employees and/or contractors) required to meet departmental and corporate objectives; supports the co-ordination of contracted activities for translation, submission of regulatory documentation and contact with local Health Authorities.
- Maintains and develops knowledge of regional regulatory requirements (e.g. new regulations and laws) that affect the further clinical development, manufacturing and commercialization of products/compounds.
- Manages, coaches and mentors direct and indirect reports.
- Performs other tasks and assignments as needed and specified by management.
- Minimum level of education and years of relevant work experience.
- Bachelor’s degree in a scientific discipline and a minimum of 10 years of progressively responsible experience in a pharmaceutical, biotechnology, contract research organization (CRO). Position also requires a minimum of 3 years of leadership experience in a regulatory affairs role.
- Special knowledge or skills needed and/or licenses or certificates required.
- Prior experience leading a Regulatory Affairs function, including the associated staff, for a growing organization, ideally combining a mix of large company best practices and smaller company adaptability.
- Prior experience with FDA CDER in the divisions of Cardiorenal, Metabolism and Endocrine, and/or GI and Inborn Errors is required.
- Prior experience in the development of drugs for Orphan Diseases and/or the pediatric indications is not required but preferred.
- In-depth knowledge of relevant regulatory guidelines and requirements, with a focus on the US, Canada, EU, and Japan.
- Demonstrated track record of success building relationships with, and influencing, regional and/or national health authorities, particularly in situations requiring direct interaction/negotiation.
- Demonstrated record of success in gaining regulatory approval.
- Hands-on experience in all phases of regulatory submissions and direct experience interacting with FDA, and other national health authorities. Direct contact and negotiation experience with such health authorities.
- Experience with Clinical Trial Applications (CTAs), and post-marketing/life cycle management (e.g. variations, renewals, labeling).
- Experience with Chemistry, Manufacturing and Control (CMC) related regulatory matters.
- Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
- Excellent verbal and written communication and skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Full Time US Employee
Michigan (Potential for right candidate to be part-time remote)