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Job

Senior Director Regulatory Affairs

  • Location

    Palo Alto

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive - Above Market Average

  • Contact:

    Bobby DeMarco

  • Contact email:

    b.demarco@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    REF - 65

  • Published:

    22 days ago

  • Expiry date:

    2021-12-05

  • Startdate:

    ASAP

Senior Director Regulatory Affairs

Location: San Francisco Bay Area, California 

Type: Full Time Permanent

Salary: Excellent salary, bonus and accompanying benefits package (Relocation provided).

Exciting opportunity to join a well rounded, recently commercialized biologics organization in Palo Alto. My client had their first Rare Disease/Pediatric BLA approval in company history and we are looking for a Senior Director to drive Global Regulatory Strategy for BLA/MAA/NDA submissions. Looking for someone who wants to be part of a like-minded, well-funded, clinical biotech that is looking to revolutionize novel medicines for children and adults suffering from certain endo diseases, globally

SCOPE:

This person will lead the implementation and development of global regulatory strategy for late stage development products, as well maintaining the life cycle management of boutique BLAs 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. The Senior Director will report directly to the SVP of Development Operations and will have a global spotlight to executive leadership.

RESPONSIBILITIES:

  • Spearhead the development and maintenance of global clinical regulatory documents including INDs, CTAs, BLAs/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
  • Biologics/Endocrinology/Rare Disease experience preferred
  • Hybrid role in Palo Alto

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