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Job

Vice President Regulatory Affairs

  • Location

    San Diego, California

  • 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:

    BD - 290

  • Published:

    14 days ago

  • Expiry date:

    2020-12-13

  • Startdate:

    ASAP

Vice President Regulatory Affairs

Location: San Diego, California 

Type: Full Time Permanent

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

Exciting opportunity to join the executive management team with an early development company to drive the development and implementation of Regulatory strategy. My client is pioneering a new class of therapies to treat serious rare disease and adding in their outstanding financial support due - this makes this role quite an exciting vacancy!

SCOPE:

This person will lead the implementation and development of global regulatory strategy for pre-IND and IND enabling products as well as spearheading product development plans 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
  • Contribute to internal cross-functional group meetings and providing regulatory input in multiple areas, including clinical study design and endpoints; preclinical pharmacology and toxicology; and CMC
  • 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

EDUCATION/EXPERIENCE:

  • Bachelors Degree required (Masters, PharmD, or PhD preferred)
  • Min of 10 years of Regulatory Affairs experience within the biopharma industry
  • Working experience in all clinical phases as it relates to Regulatory Affairs submissions/interactions
  • Rare Disease experience is preferred
  • Demonstrated success in drug development

SKILLS:

  • Well-rounded knowledge of FDA and EMA regulations
  • Relevant submission filing/approval experience 
  • Top notch communication skills
  • (INDs/CTAs/NDAs/BLAs) in leading negotiations with global health authorities
  • 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 is not 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