Current Openings

ChemGenex is an equal opportunity employer. We strive to to attract, develop and retain highly qualified individuals representing the diverse communities in which we live.

Director, Regulatory Affairs

The Position:

The Director, Regulatory Affairs will be responsible for preparing, implementing, communicating, and coordinating regulatory projects, plans, and schedules with scientific (clinical and preclinical), manufacturing, and commercial project team members for drug products proposed for oncologic indications.  The successful candidate will assist with the preparation, completion, and submission of NDA’s marketing authorization applications (MAAs), pre-commercialization and launch activities.  He/she will lead and provide expertise on promotional, labeling, product defense, and development strategies for marketed products, represent the company in external interactions and act as liaison between DDMAC and other divisions within the FDA. This position reports to the Senior Director, Regulatory Affairs and is located in Menlo Park, California.

Responsibilities:

  • Actively contribute to the development and implementation of U.S. regulatory strategies for specific projects, including identifying and assessing regulatory risks, serving as the regulatory representative on project teams and as the regulatory contact with relevant regulatory authorities.
  • Continually monitor the regulatory environment, interpret new regulations, guidances, and enforcement activities/trends, and evaluate the impact on external environments and the business i.e. competition.
  • Work closely with Marketing, Legal, and Clinical/Medical Affairs in the development of advertising and promotional materials (both electronic and hard copy) and commercial compliance policies to support the commercial interests of the business.
  • Ensure compliance with applicable FDA and state regulations and those of other Regulatory Agencies.
  • Develop processes and procedures relevant to the creation, review and approval of advertising, promotional and labeling materials.
  • Support labeling development and negotiations with FDA; oversee launch activities.
  • Provide input and advice into local implementation of global promotional campaign strategies.
  • Ensure promotions and advertising materials are updated to be consistent with current labeling.
  • Maintain awareness of the promotional regulatory environment with the FDA and understand international/global promotional issues.
  • Serve as the primary contact, leading and facilitating communications with the FDA Division of Drug Marketing and Communications (DDMAC) and direct the timely submission of all applicable approved promotional materials to the FDA and to other Regulatory Agencies, as required.
  • Manage the maintenance of records and databases that support communication with DDMAC and other Regulatory Agencies.
  • Manage the regulatory submission process for NDAs through to approval, including management and coordination of the preparation of all regulatory documentation, as required.
  • Deliver regulatory compliance training to members of Medical Affairs and the sales and marketing groups.
  • Review protocols, reports and all types of regulatory documentation (quality, safety, efficacy, and labeling).
  • Collect, prepare, and assemble documentation required for Investigational New Drug Applications, Clinical Trial Applications, New Drug Applications, Marketing Authorization Applications.
  • Provide guidance to team of Technical Writers and Publishers.
  • Support team members’ growth through mentoring and sharing of experience and knowledge.

Requirements:

  • Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, MBA)
  • 7+ years experience in pharmaceutical/biotechnology industry experience, 5+ years regulatory experience working with CDER
  • Proven track record managing regulatory process for commercial products, preferably in oncology therapeutic area, including promotional materials through DDMAC process, and involvement in labeling discussions with FDA
  • Experience leading an integrated internal regulatory review process interacting with key marketing and sales personnel, clinical/medical affairs, legal and external medical education/advertising vendors
  • Heavy knowledge of post-marketing regulatory requirements
  • Experience with label negotiation, risk management plans, pharmacovigilence systems, DDMAC preferred
  • Experience with regulatory agency interactions and preparation of documentation to support interactions
  • Knowledge of European regulatory affairs preferred
  • Direct manufacturing or clinical experience a plus
  • Experience with preparation and submission of NDA through to authorization, preferably in oncology therapeutic area
  • Ability to work both independently with minimal direction and within project teams, committees, etc. to attain business goals
  • Excellent verbal and written communication skills
  • Demonstrated strong organizational skills, including the ability to prioritize
  • Strong interpersonal skills and the ability to deal effectively with various professionals, including medical, scientific, and manufacturing staff
  • Excellent computer skills, including all MS applications
  • Ability to travel


To apply, please submit your resume to careers@chemgenex.com

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