$200K — $250K *
SUMMARY: We are seeking a motivated and ambitious individual to support global regulatory activities to achieve MyoKardia’s strategic vision in obtaining worldwide approvals to market our products.
Specific Responsibilities for Position:
The Director will be the Regulatory Lead for one or more development programs in cardiovascular disease, and work closely with cross-functional teams and development partners to execute the global regulatory strategy in line with the project team’s goals, health authority expectations, 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 Strategy.
Responsible for leading regulatory activities for assigned projects in line with ICH requirements, regional requirements, and company policies and procedures.
Responsible for global regulatory strategy for one or more programs, identifies and proposes risk mitigation strategies, and influences project teams and sub-teams.
In partnership with cross-functional project team, develops clinical and nonclinical development strategy to support marketing authorization.
May prepare and/or manage complex submissions that require cross-functional interaction with departments outside of regulatory affairs.
Serve as the Regulatory Affairs representative on assigned teams and assures the progress of projects by providing direction, solutions and feedback to the teams in support of development activities and regulatory approvals.
Support 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 future global NDAs / MAAs.
Interact with Regulatory Affairs personnel within external service providers and development partner companies.
Maintain knowledge of current regulatory requirements and communicates changes in regulatory information to cross-functional teams and senior management. Recognized as an expert resource for regulatory advice across departments.
Plans, schedules and arranges own activities and those of direct report(s).
Bachelors or advanced degree in a scientific discipline, with a minimum of 10 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, NDA/BLA/MAA, or supplements/variations.
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, written, negotiation, influence and interpersonal communication skills are required.
Capable of critically reviewing complex technical/scientific documents and influencing colleagues across functions.
Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others; prior management experience desirable.
Valid through: 8/26/2020
$150K — $200K
12 days ago