Executive Director Regulatory Affairs

Location: San Diego, California (100% Fully Remote Opportunity)

Type: Full Time Permanent

Salary: Excellent salary, bonus and accompanying benefits package (Relocation provided for exceptional candidates)

Exciting opportunity to develop and lead Regulatory Strategy for my client's strong, clinical oncology portfolio. My client is in an excellent financial position and is looking to file their first ever NDA at the end of 2021! This vacancy will allow the right person to get hands on NDA submission 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.

SCOPE:

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 

RESPONSIBILITIES:

• 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

EDUCATION/EXPERIENCE:

• Bachelors Degree required (Masters, PharmD, or PhD preferred)
• Min of 10 years of Regulatory Affairs experience within the biopharma industry
• Gene Therapy/Cell Therapy experience preferred

SKILLS:

• 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 b.demarco@hamlynwilliams.com