Cytokinetics, Inc. is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions. Working collaboratively, Cytokinetics? devoted and passionate personnel are focused on advancing novel therapeutics to dramatically improve the lives of patients. With purpose and passion, we have committed to make an important impact on serious medical illnesses.
Reporting to the Senior Vice President of Regulatory and Compliance, the Associate Director/Director of Regulatory Affairs is responsible for leading activities of Regulatory Affairs with emphasis on global regulatory strategy and the preparation, review and submission of documents to FDA and other regulatory authorities
Provides current regulatory intelligence and formulates regulatory strategies.
Oversees implementation of regulatory strategy and activities needed to secure approval of new drugs.
Oversees coordination, preparation and timely submission of regulatory documents.
Maintains current knowledge and expertise of FDA/EMA regulations and ICH guidelines.
Provides regulatory advice to other functional areas.
Serves as a principal interface with reviewers from FDA and other health authorities
Identifies perceived gaps in product development plans that may pose regulatory issues
Participates in regulatory due diligence activities.
Develops and maintains relationships with external vendors and regulatory health authorities.
Coordinates preparation of responses to queries from regulatory authorities.
Coordinates activities pertaining to meetings and conferences with FDA, EMEA, and other regulatory authorities
Maintains relationships and collaborates with partners to improve effectiveness in regulatory strategies.
Mentors department personnel and updates appropriate departments on the current regulatory environment.
Supervises employees, consultants/contractors in Regulatory Affairs
Optimizes employee performance by developing employees and promoting career growth.
Develops and implements regulatory operating guidelines and common work practices/strategies within the team.
o 10+ years of drug development and regulatory affairs experience in the Biotech/ Pharmaceutical industry.
o Advanced degree MD, Pharm.D. or Ph.D. preferred
o Extensive experience in drug development and approval process (INDs, NDAs, MAAs) across all phases of development.
o Demonstrated ability to interpret and stay current with FDA and other regulatory agency regulations and guidelines.
o Experience with eCTD requirements and electronic submissions
o Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions.
o Demonstrated knowledge of regulatory aspects of Chemistry, Manufacturing and Controls and quality assurance, is a very strong plus.
o International experience is desired
o Orphan drug experience is a plus
o Experience with labeling requirements is a plus
o Demonstrated management expertise, including leadership and development of employees.
o Ability to work effectively across teams, functions and with outside partners.
o Excellent oral and written communication skills.
o Excellent organizational skills and attention to detail.
Now is the perfect time for you to consider a move to Cytokinetics where you can put all of your skills to maximum use. You will enjoy a truly unique culture as well as a superior flexible benefits program.