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About our client
Our client is a rapidly growing biotech company headquartered in San Diego that is focused on the development and commercialization of various oncology and infectious disease therapeutics. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees.
Position	Location
Regulatory Affairs Manager	San Diego, California
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Prepare information necessary for investigational, marketing and post-licensure regulatory submissions (INDs, IND amendments, BLA/NDAs, etc.) 2) Develop and maintain QA structure for regulatory submissions in accordance with overall quality structure 3) Prepare information as per regulations and relevant guidelines (domestic, national and international) 4) Produce high quality submissions using electronic systems 5) Prepare, and review/approve routine regulatory submissions, including annual reports and safety reports 6) Provide technical writing assistance to creators of submission documents
Requirements
1) Bachelor's degree with 5+ years of pharmaceutical industry experience 2) Minimum 3 years of experience with pre/post-marketing regulatory submissions 3) Experience in preparation & submission of INDs and BLA/NDA 4) Ability to implement/manage projects and work well in a deadline-driven environment 5) Work independently with minimal supervision 6) In-depth knowledge of US/ICH guidelines 7) Understanding of processes/interactions essential for the production of regulatory submissions 8) Excellent computer skills