Manager of Regulatory Affairs

Reporting to the Director of Regulatory Affairs, this individual will provide strategic input and operational regulatory support to cross-functional teams responsible for development and registration of Constellation’s pipeline candidates. The individual will also ensure effective communication and constructive working relationships with external collaborators and regulatory authorities.  We are #BrighterTogether

 

How you will spend your day:

  • Work cross-functionally with clinical, chemistry, manufacturing & controls (CMC), nonclinical, and pharmacovigilance to develop and execute regulatory strategy and submission plans for quality and timely filings
  • Act as regulatory lead for assigned program (s) and provide robust regulatory guidance regarding FDA and international (Canada, EU and Asia-Pacific) regulatory requirements for global clinical development and registration of oncology drugs
  • Author and review regulatory documents in compliance with regulatory requirements
  • Support regulatory interactions with FDA and international regulatory bodies including preparation of briefing documents
  • Manage and ensure compliance with all reporting requirements including annual and periodic reports
  • Provide strategic guidance for and author applications related to designations for expedited programs or special status
  • Represent the regulatory affairs function in project teams to provide regulatory support and advice
  • Identify and assess regulatory risks for assigned programs to develop and implement short and long-term regulatory strategies
  • Participate in regulatory intelligence efforts
  • Draft and/or modify applicable SOPs and/or written practices relating to the regulatory affairs function

 

Key things about you:

  • Bachelor’s degree, MS or advance degree a plus, Life/Health Sciences preferred
  • 3+ years regulatory drug development experience
  • Experience in late phase drug development
  • Experience in rare disease or oncology drug development a plus
  • Experience with regulatory submission procedures and regulations, preparation and writing regulatory documentation to support agency interactions
  • Experience with IND / CTA / marketing applications
  • Solid working knowledge of drug development process and US regulatory requirements required; knowledge of EU, Canada, and ROW regulatory requirements a plus
  • Strong project management skills including familiarity with PM toolkits
  • Ability to work both independently with minimal direction and within project teams to achieve department goals
  • Demonstrate excellent written and oral communication skills
  • Demonstrate strong organizational skills
  • Strong interpersonal skills and the ability to work effectively with a variety of disciplines including medical, scientific, and technical functions

 

Apply Online »


Constellation Pharmaceuticals is an Equal Opportunity Employer, a participant in E-Verify and offers a comprehensive benefits package, including health, dental, 401(k), paid vacation, tuition reimbursement, and much more.

We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.