Main Purpose of the Position:
Responsible for the maintenance of various clinical and nonclinical regulatory documents, including INDs/BLAs/NDAs. Ensures that the elements, quality, accuracy and format of regulatory submissions comply with applicable
laws, regulations and corporate standards. Represents regulatory affairs at subteam meetings.
Job Duties/Responsibilities:
Serves as the regulatory representative on various project subteams and
addresses a variety of problems of moderate scope
Documents teleconferences and meetings with health authorities
Works under very general supervision
Collaborates with the regulatory information, CMC and commercial groups of
Regulatory Affairs
Works on computer for extended periods of time
Implement project plans and adhere to timelines for multiple projects
Perform literature searches, prepare special reports and assemble
documentation to support project teams
Participates in department initiatives, task forces, and training
Any other tasks as requested by management to support business activities
Qualifications: Education, Experience, Knowledge and Skills:
(Minimum requirements)
Education: Bachelor’s degree required
Proprietary – For Genentech Internal Use Only 10/12/2006 2
Years of Experience: Two – four years drug development or related experience
Skills: Strong oral and written communication, attention to detail, and ability to
prioritize and implement multiple activities/projects, adherence to timelines,
flexibility and willingness to adapt in a changing environment
( Preferred requirements )
Possess knowledge of FDA regulations, ICH guidelines and awareness of overall
