San Francisco Bay Area
Competitive - Above Market Average
4 months ago
Senior Director Regulatory Affairs
Location: San Francisco Bay Area, California
**also have similar roles in LA & San Diego
Type: Full Time Permanent
Salary: Excellent salary, bonus and accompanying benefits package (Relocation provided). Remote potential!
Exciting opportunity to join a well rounded clinical oncology biotech on the verge of approval! My client filed their first NDA back in March and has another planned in February 2021 and the Senior Director will have the opportunity to guide one of the products through global registration. Looking for someone who wants to be part of a like-minded, well-funded, clinical biotech that is looking to revolutionize novel medicines for cancer patients globally.
This person will lead the implementation and development of global regulatory strategy for pre-IND and clinical products, as well maintaining the life cycle management of boutique Oncology NDAs leading to successful registration. Ideally, this person would have managed teams in the past and would be able to lead from the front. This person will also provide the oversight of cross functional teams as well as liaison with key health authorities around the world, including FDA, Health Canada, EMA etc
- Spearhead the development of clinical regulatory documents including INDs, CTAs, NDAs and MAAs.
- Provide the regulatory strategic leadership on drug development, while maintaining corporate objectives
- Provide leadership and hands on support when needed to the regulatory team in managing, planning, coordinating and preparing all documentation submitted to Health Authorities in support of INDs, MAAs, DMFs, CTAs, safety reports and annual updates
- Communicate on a consistent basis with stakeholders, internally and externally, in order to comply with all noted objectives and deadlines
- Manage regulatory team through promotions
- Bachelors Degree required (Masters, PharmD, or PhD preferred)
- Min of 8 years of Regulatory Affairs experience within the biopharma industry
- Small Molecule Oncology experience preferred
- Well-rounded knowledge of FDA and EMA regulations
- Relevant submission filing/approval experience (INDs/CTAs/NDAs/BLAs) in leading negotiations with global health authroirities
- Experience with preparing all types of regulatory documentations relative to submission needs
- Strategic thinker with the ability to thrive in a collaborative, fast paced environment
I manage a range of other permanent and freelance positions for a broad portfolio of clients (Biotech, CRO and Pharma). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Contact Bobby DeMarco at (646)-349-4344 or at firstname.lastname@example.org