Director | CMC Regulatory Affairs
Constellation’s Development team is growing and we are seeking an experienced and highly motivated CMC Regulatory Director. The ideal candidate will have a strong background in CMC disciplines and especially in regulatory strategies for small molecule development for oral products. Additionally, the successful candidate will have broad experience in the creation and submission of regulatory dossiers at various stages of clinical development to advance and support our small molecule portfolio from exploratory clinical development through NDA enabling development and eventually product launch. We are #BrighterTogether.
The CMC Director will leverage internal and external partners and ensure phase appropriate global regulatory requirements are embedded during the development of drug substance, drug product and analytical development of pipeline projects. Candidates who are enthusiastic team players and have a passion for playing a key role in the development of life-saving medicines are encouraged to apply. Expertise in small molecule development including oral formulation and process development is required.
How you will spend your day:
- You will ensure that all global regulatory guidance requirements are considered during the development of drug substance and drug product
- You will work with CMC team and external collaborators to identify gaps in relation to global regulatory requirements and develop strategies to strengthen scientific rationale to mitigate any regulatory risk
- You will strongly interface with the CMC development team (internally and externally) to ensure knowledge required for regulatory submissions is understood by the development team and plans are laid out for timely generation of the required data
- Lead and manage the preparation of CMC documents and submissions, including INDs/CTAs/IMPDs, NDAs/MAAs, amendments, supplements, responses to information requests, and briefing documents for regulatory agency interactions.
- Work with the CMC team as well as external collaborators to prepare for and conduct CMC-related meetings with regulatory agencies.
- Interact effectively with cross-functional stakeholders, including colleagues in Regulatory, Clinical, CMC and QA, as well as external partners.
Key things about you:
- Leadership experience in the preparation of CMC dossiers for clinical stage and marketing authorization applications (multiple filings)Combination of experience in CMC development group and Regulatory Affairs
- You will offer a Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences or related disciplines (MS degree candidates with substantial direct experience in CMC will also be considered)
- You will be able to offer a minimum of 10 years’ experience of relevant small molecule CMC development
- Understanding of the drug development process including drug substance development, drug product development, and related Quality requirements
- Experienced in planning and execution of pre-approval inspections with global regulatory agencies
- You will possess strong project management, interpersonal, and communication skills
- You will be proficient in the authoring and reviewing of CMC sections of regulatory dossiers
- You have a desire to work in a fast-paced, dynamic environment
- A high degree of autonomy; takes accountability for work
- You are naturally organized and efficient and are known for delivering high-quality work
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, 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.