SUMMARY: We are seeking a motivated and ambitious individual to provide leadership and support to global regulatory activities to achieve MyoKardia’s strategic vision in obtaining worldwide approvals to market our products. The individual will represent Regulatory Affairs and work closely with cross-functional teams and development partners while managing relationships and interactions with external strategic and technical regulatory service providers in accordance with health authority and ICH requirements. In addition to being a key member of our project teams, she/he will provide organizational support as the company and its product development pipeline grow. This role will report to the Head of Regulatory Affairs.
ESSENTIAL DUTIES & RESPONSIBILITIES
Develop and implement regulatory strategies to facilitate the progress for assigned programs in all phases of development.
Serve as the Regulatory Affairs representative on assigned project teams and assure the progress of projects by providing direction, solutions and feedback to the teams in support of regulatory approvals.
Lead interactions with regulatory agencies for assigned programs.
Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while planning for global NDAs / MAAs.
Interact with Regulatory Affairs personnel within external service providers and development partner companies.
Maintain awareness of current regulatory requirements and communicate requirements in support of regulatory approvals.
Bachelors or advanced degree in a scientific discipline, with a minimum of 10 years experience working in a regulated environment, at least 6 years of regulatory experience in the biopharmaceutical industry; cardiovascular experience a plus and experience with orphan drug development and pediatric drug development desirable.
Direct experience with pharmaceutical regulatory submissions and product approvals, managing major regulatory filing(s) such as IND/CTA or NDA/BLA/MAA.
Extensive knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices.
Demonstrated leadership and success in management of regulatory activities with a proven track record of effective collaboration with regulatory agencies, including the FDA.
Excellent verbal and written communication skills.
Collaborative, analytical and interpretative skills that enable review and compilation of reports and other documents used in regulatory planning and submissions.
Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others; prior management experience a plus.
Previous experience in successfully leading assigned activities within cross-functional teams.
Some travelrequired. Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.