Manager/Sr. Manager of 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 can 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 operational regulatory support and strategic input to regulatory affairs and cross-functional teams responsible for development and registration of Constellation’s pipeline candidates.
In this role you will:
- Works with the regulatory leads to operationalize regulatory strategies including, but not limited to, compiling regulatory submissions such as INDs, CTAs, Amendments, Agency meeting briefing books and support major submissions such as NDAs/MAAs
- Responsible for coordinating all aspects of regulatory submissions relevant to assigned programs, ensure compliance with all reporting requirements including annual and periodic reports. This includes liaising with external Regulatory partners (CROs, Consultants, Contractors) to ensure completion of regulatory objectives.
- Represent the regulatory affairs function at project teams to provide regulatory support and advice
- Create and maintain regulatory submissions tracker and timelines, archiving of submissions and provide key support to manage documents within Constellation’s electronic document management system
- Perform Regulatory intelligence activities to support development programs
- Interpret and present relevant regulatory guidance documents to the regulatory team and/or cross-functional program teams
- Draft and/or modify applicable SOPs and/or written practices relating to the regulatory affairs function
We are looking for people who offer:
- Bachelor’s degree, MS or advance degree a plus, Life/Health Sciences preferred
- 2-5 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 / eCTD requirements
- Solid working knowledge of US regulatory requirements required; knowledge of EU, Canada, and ROW regulatory requirements a plus
- 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 and project management skills
- Strong interpersonal skills and the ability to work effectively with a variety of disciplines including medical, scientific, and technical functions
Don’t see the position you’re looking for? We want to hear from you regardless! Please submit your CV to us at firstname.lastname@example.org
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, gender expression, partnership status, status as a protected veteran, status as an individual with a 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.