Director, Regulatory Affairs is responsible for providing Regulatory support to Goldbug Strategies’ clients. This position will provide strategic and tactical support to Goldbug’s internal team and clients. This position is responsible for assisting in defining and executing the regulatory strategy and project plan, researching precedents, and developing content for all deliverables in the Project Regulatory Plan, as appropriate, including regulatory submissions. In addition, they will ensure adherence to established processes, policies and procedures of the company and clients (as required).
- Responsible and accountable for defining and executing regulatory strategy, researching precedents, providing regulatory guidance and support to Goldbug’s internal team and client’s product development teams throughout the Total Product Life Cycle (TPLC).
- Authors, reviews, edits, coordinates, assembles, and prepares submission documents to FDA, including Q-Sub documents, PMA and/or De Novo 510(k) submissions, and the respective supplements and/or amendments to the above submissions, post-marketing supplements, etc.
- Engages regulators, when necessary, in verbal and written communications to discuss pending or new submissions, regulatory requirements, address questions, etc.
- Embraces being a Regulatory subject matter expert with an external focus on regulatory intelligence, proactively and constantly keeping current in regard to US regulations, guidance documents, Federal Register notices, etc., and competitor news – across all aspects of the TPLC in the technology and therapeutic focus areas of Goldbug Strategies’ business.
- Conduct training and/or proactively share effectively and efficiently any appropriate news, resource materials, etc., so as to build Goldbug’s knowledge base.
- Effectively apply regulatory intelligence and knowledge gained through research and review of precedents across Goldbug clients to enrich regulatory strategies and/or internal processes applied to clients.
- Participate in business meetings with existing and prospective clients, as appropriate.
- Minimum of 8 years of Regulatory Affairs experience in In Vitro Diagnostics. Experience must include De Novo and/or PMA Submissions.
- Demonstrated experience in multiple aspects of Regulatory Affairs throughout the TPLC including regulatory pathway/strategy development, analytical and clinical validation requirements, design control, Quality Systems, post-marketing requirements, etc.
- Experience representing Regulatory on project teams providing proactive and successful regulatory advice and strategy.
- Successful experience in effective communication between companies and Regulatory Agencies.
- Minimum requirement of a bachelor’s degree in life sciences, bio-engineering or related science. Advanced degree (MS or PhD) in life sciences preferred.
Skills and Qualifications
- Overall positive “can-do” attitude and service-minded approach.
- Excellent written and verbal communication skills, including presentation and technical writing skills. Demonstrated ability to communicate clearly, succinctly, and effectively in person, over the phone, and in writing. Comfortable communicating with executive management/leaders.
- Strong interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.
- Ability to work as a member of a team in a timeline-driven environment with limited supervision.
- Must be self-driven, capable of operating autonomously.
- Must possess strong organizational skills. Detail-oriented yet can see the “big picture”; able to handle multiple projects concurrently.