Sr. Director, Regulatory CMC
Senior Director, Regulatory CMC 1321461
Location: Watertown, MA (Hybrid)
Science/ Focus: Small Molecule
Therapeutic Area(s): Viral infections and liver diseases
Job Overview: The Sr. Director, Regulatory CMC will create the strategy, lead the execution and manage the regulatory submissions for a variety of global programs (early and late stage).
Responsibilities:
- Lead regulatory CMC strategy and submission aspects for assigned programs
- Direct CMC focused regulatory submission activity
- Collaborate with internal and external stakeholders to manage programs and ensure regulatory compliance during product development, validation and commercialization
- Partner with CMC experts to provide responses to global health authority questions
- Communicate with FDA and other health authorities
Qualifications:
- MS or PharmD (preferred)
- 10+ years’ experience within pharmaceutical or biotechnology industry
- 8+ years’ experience in regulatory affairs CMC (US and International)
- Experience across both large and small molecule drug development (preferred)
- Global clinical trial and marketing applications, eCTD submissions and electronic document management systems (preferred)
- Experience preparing and submitting documents to FDA (Investigational New Drug (INDs), New Drug Applications, (NDAs ), Marketing Authorizations Application (MAA), Clinical Trial Application (CTA) or Investigational Medical Product Dossier (IMPDs)
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
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EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.