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Job

Senior Director Regulatory Affairs

  • Location

    Los Angeles, California

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Bobby DeMarco

  • Contact email:

    b.demarco@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • Expiry date:

    2020-10-17

  • Startdate:

    ASAP

Senior Director Regulatory Affairs – Oncology

Location: Los Angeles 

Type: Full Time Permanent

Salary: Excellent salary, bonus, equity package and accompanying benefits (Expansive Relocation Package)

Exciting opportunity to develop and lead Regulatory Strategy for my client's strong clinical oncology portfolio. Looking for someone who wants to be part of a like-minded, well-funded, clinical biotech that is looking to revolutionize cell therapy technology for novel medicines 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, BLAs 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
  • Proven Drug Development success
  • Cell Therapy experience preferred
  • Relevant submission filing/approval experience (INDs/CTAs/NDAs/BLAs) in leading negotiations with global health authroirities

SKILLS:

  • Well-rounded knowledge of FDA and EMA regulations
  • Ability to work cross functionally and with stakeholders accordingly
  • 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