Associate Director, Regulatory Affairs
Constellation Pharmaceuticals is a pioneering epigenetics company, focused on the discovery and development of novel, small molecules targeting chromatin regulatory proteins in tumor and immune cells for therapeutic applications in oncology. We are currently entering late-stage clinical trials and preparing for commercialization and launch of our lead product candidate. We believe that each team member has the ability to impact and improve the lives of patients and that we are #BrighterTogether.
Reporting to the Director of Regulatory Affairs, this newly created role will provide strategic input and operational regulatory support to cross-functional teams responsible for development and registration of Constellation’s pipeline candidates. The Associate Director of Regulatory Affairs will also ensure effective communication and constructive working relationships with external collaborators and global regulatory authorities.
How You Will Spend Your Day:
- Work cross-functionally with clinical, nonclinical, and pharmacovigilance groups to develop and execute regulatory strategy and submission plans
- 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
- Lead regulatory interactions with the 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
- 5+ years regulatory drug development experience
- 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
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Constellation Pharmaceuticals recognizes the value of diversity in our workforce. We are committed to equal opportunity. We consider all qualified employment applicants without regard to race, religion, color, gender, age, national origin, sexual orientation, gender identity, partnership status, protected veteran status, disability, or any other status protected by federal, state, or local law. Individuals who hold legal work authorization applicable to employment at Constellation Pharmaceuticals in the United States will be considered without regard to citizenship/alienage. Constellation Pharmaceuticals is a participant in E-Verify.
We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.