Director Regulatory Affairs
Medical Device/ Pharmaceutical
As a part of the Regulatory Affairs team, the Director will work with Department management and project team members to identify and execute regulatory strategies to support clinical development and commercialization of company products globally. Execute project tasks relevant to regulatory affairs throughout product lifecyle(s). A unique position with exposure to medical device, pharmaceutical product development, drug / device combination products, advertising and promotion influence, non-clinical, clinical and CMC strategy support.
- Responsible for assisting in the preparation and compilation of domestic and international product submissions, with guidance. This may include, but is not limited to: PMAs, 510ks, international dossiers and/or CE technical files; INDs, NDAs, MAAs, NDS and global CTAs.
- Responsible for agency establishment registrations and device/drug listings.
- Assist with the preparation and compilation of regulatory information requested during regulatory inspections.
- Support domestic and international field corrective actions and adverse event reporting, when necessary.
- Assist in response to Health Authority inquiries.
- Assist in the development and submission of any necessary global CTAs, maintain global CTAs throughout development lifecycle for pharmaceutical products.
- Review product and process documentation for assigned projects to ensure compliance with regulatory dossiers.
- Assist in the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes.
- Coordinate development and submission of annual Developmental Safety Update Reports.
- Provide regulatory research information as requested.
- Perform other regulatory affairs duties when requested.
Ability to manage one or more direct reports
- Bachelor's degree in engineering, science, and/or health profession field.
- 10+ years' experience in regulatory affairs in the pharmaceutical industry; 3-5 years of experience in a managerial role.
- Demonstrated experience in preparing and gaining acceptance for all types of US based submissions, PMA submission experience and global investigational and commercial submission experience preferred.
- Proven track record of increasing responsibilities with skills in leadership and management.
- Be a self-starter and have the ability to work independently to drive projects in accordance with established company objectives.
- Strong understanding of global regulatory affairs regulations and expectations.
- Strong team member with ability to identify and drive process improvements.
- Excellent verbal and written communications skills.
- Excellent organizational skills and attention to detail.
- Mostly office based in Mass. with ability to travel approximately 5 - 10% (domestic and some international) for applicable meetings and/or educational seminars.