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Job #02973

About our client Our client is a biopharmaceutical company based in San Diego. They focus on in-licensing, developing and commercializing therapeutics for the treatment of cancer and infectious disease. Coupled with these is an experienced management team with significant product development, clinical, regulatory, finance and business management expertise. This is a great opportunity for the right individual to join a dynamic company! Position Location Senior Director, CMC Regulatory Affairs San Diego, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Prepare information for investigational, marketing and/or post-licensure regulatory submissions (INDs, BLA/NDAs, BLA/CMC supplements, etc.) as per regulations (domestic, national and international) 2) Prepare CMC portion of the IND and NDA in CTD format 3) Develop and maintain quality assurance structure for regulatory submissions as per overall quality structure 4) Prepare labeling with full prescribing information 5) Participate in multiple product and project teams 6) Prepare, review and approve routine regulatory submissions, including annual reports, periodic safety reports, etc. (as necessary) 7) Produce high-quality regulatory submissions using electronic publishing systems 8) Provide technical writing assistance to authors of submission documents 9) Oversee assigned activities with the Project Team 10) Represent Regulatory Affairs in due diligence activities (as required) 11) Write reports of due diligence activities and provide recommendations 12) Operate to the highest ethical and moral standards 13) Comply with company policies and procedures 14) Adhere to quality standards set by regulations as well as company policies, procedures and mission 15) Communicate effectively with supervisors, colleagues and subordinates 16) Maintain positive working relationships with co-workers and others while understanding and appreciating personal and work style differences of individuals 17) Provide administrative leadership and knowledge-based expertise in related areas that can be applied to meeting strategic goals 18) Demonstrate emotional maturity when confronted with difficult situations 19) Retain a positive and optimistic (yet realistic) outlook while working under pressure 20) Perform other duties as required Requirements 1) Bachelor’s degree (preferably in Life Sciences) 2) 8+ years of experience in pharmaceutical/biotech with at least 5 years in a management role within Regulatory Affairs 3) Working knowledge of US and ex-US regulatory guidelines 4) Excellent organizational and communication skills 5) Ability to work well in a deadline-driven environment 6) Ability to support multiple projects simultaneously 7) Willingness and ability to travel (as needed)