Browse New and Exciting Opportunities

Senior Director, Regulatory Affairs

New York, NY 10002

Posted: 03/21/2023 Employment Type: Direct Hire Job Category: Regulatory Job Number: 3519

Job Description

Our client is an early clinical-stage start-up biopharmaceutical company founded by an experienced and successful biotech entrepreneur.  They have an exciting pipeline with preclinical programs supportive of multiple clinical indications.

The Sr. Director of Regulatory Affairs will initiate regulatory strategy across multiple molecules and indications, will lead on regulatory submissions and regulatory body interactions, and will have the opportunity to build a regulatory department.  

Essential Functions: 
The responsibilities of this job include, but are not limited to, the following:
  • Global regulatory strategy for multiple molecules in a range of indications
  • Consideration for label optimization, shortest times to approval, multiple indications
  • Coordination of preparation, submission and follow-up from IND to NDA of both CMC and clinical components - most immediately for:
o    Pre-IND meeting requests
o    Responsible for IND briefing packages
o    Responsible for coordinating responses for RFIs
o    Ad-hoc meetings
o    Orphan/Peds/FastTrack/Breakthrough
  • Liaising with FDA and global regulatory agencies
  • Establishing regulatory submission timelines with clinical and CMC
  • Serving as regulatory lead on CMC
  • Reviewing protocols, CSRs, IBs
  • Developing/contributing to regulatory SOPs
  • Interacting with PV function (together with medical/clinical)

Requirements / Qualifications:
  • BS, MS, PhD in relevant scientific/analytical field: 
o    Minimum BS in a science and minimum 10 Years of regulatory experience in the pharma or biotech industry.  
  • Knowledge and experience in small molecule development
  • History of interaction with FDA, EMA, MHRA; additional regulatory bodies a plus
  • History with additional expedited review and special designation pathways
  • Knowledge of all phases of drug development from pre-clinical to post marketing trials, with an emphasis on Ph 1-3 clinical trials.
  • Demonstratea a collaborative approach when working with colleagues and internal / external partners and stakeholders.
  • Ability to proactively identify and mitigate risks that impact drug development and /or regulatory submissions.
  • Strong problem-solving skills
  • Excellent communication skills, both written and verbal
  • Must be fluent in English
  • Detail oriented and possesses technical expertise (e.g., spreadsheets, metrics, and data flow management)
  • Willingness to travel when necessary.
Apply Online
Apply with LinkedIn Apply with Facebook Apply with Twitter

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.