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Director of Regulatory Affairs$ 200,000+


Ref: BD-135

Location: Boston, MA

Type: Permanent


Exciting opportunity in Regulatory Strategy to work on pre-IND oncology products for a private, clinical stage Biotech in Boston.

~TWO OPENINGS~

*Excellent relocation package provided
*Competitive compensation package
*Must be a DRIVER and a LEADER working with cross functional teams
*Short Term & Long Term Bonus - Cash based

 

Scope:
This person will be tasked with developing and implementing regulatory strategy for pre-IND/early phase products, as well as life cycle management of unique oncology applications leading to successful registration. This person will also provide the oversight of cross functional teams as well as liaison with the FDA and other necessary authorities.
 
Responsibilities:

  • Lead the direction in the development of clinical regulatory documents including INDs, CTAs, BLAs, DMFs, NDAs and MAAs.
  • Provide the regulatory strategic leadership on application development productions, including the implementation of corporate objectives, dealing with submissions, and other regulatory requirements
  • Provide leadership and hands on support when needed to the regulatory team in managing, planning, coordinating and preparing all documentation submitted to the FDA in support of INDs, BLAs, MAAs, DMFs, CTAs, safety reports and annual updates to the board
  • Communicate regulatory with stakeholders, internally and externally, in order to comply with all noted objectives and deadlines
  • Create and maintain Regulatory Strategic Development plans and provide strategic input in global product development planning.

 

Education/Experience:

  • Bachelors Degree required (Masters, PharmD, or PhD preferred)
  • Min of 8-10 years of Regulatory Affairs experience within the biopharma industry
  • 3-7 years of Oncology experience necessary
  • Need IND filing experience/Clinical RA experience

 

Skills:

  • Well rounded knowledge of FDA and EMA regulations
  • Relevant filing experience (INDs and NDAs) in leading negotiations and Health Authority interactions as well as FDA Advisory Committee Meetings (e.g. ODAC). Experience with regulatory filings in oncology is preferred.
  • 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

 

Salary: $200,000+ Per annum

Bobby DeMarco Jr.

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