- Provides strategic global regulatory guidance to cross-functional project teams responsible for product development.
- ctively leads the development and implementation of regulatory strategies for assigned programs and ensures cross-functional alignment.
- Coordinates regulatory activities (CMC, nonclinical, and clinical) to assure timelines and milestones.
- Supports departmental activities with regards to clinical trial conduct and regulatory submissions.
- Provides Regulatory Risk Assessment (RRA) during various phases of product development.
- Monitors current and proposed regulatory and legal issues and ensures that key initiatives are communicated to the stakeholders.
- Monitors/ensures all aspects of regulatory submissions relevant to assigned projects.
- Supervises the preparation of regulatory submissions to ensure timely submission and compliance with regulations and guidelines.
- Reviews and approves (when necessary) documents used in regulatory submissions.
- Participates in preparing IMPDs to support international CTA submissions.
- Reviews technical documents (Clinical, Nonclinical, CMC).
- Provides Regulatory support as a key member of Global Regulatory Project Teams.
- Leads multidisciplinary team responding to Health Authority questions during the IND and NDA review phases for assigned projects.
- cts as liaison between Regulatory Affairs and other functional areas, including external contractors (e.g., contract research organization teams and vendors).
- Maintains knowledge and monitor changes in pertinent laws, regulations, and guidance.
- Interprets external developments and inform/educate internal stakeholders.
- Identifies the need for new regulatory processes and SOPs, approves and ensures implementation.
- Works closely with Regulatory Operations to ensure e-CTD compliance.
- B.S. degree in a scientific discipline.
- M.S. or equivalent experience is preferred.
- Minimum of 7 years of regulatory experience respectively within the pharmaceutical or biotechnology industry.
- Experience in the development of drugs, biologics/vaccines, and in the rare disease space.
- Experience designing and executing creative development strategies for NCE and biologics development programs.
- Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial Applications and Marketing Applications in eCTD format.
- Experience with international clinical trials and regulatory documentation.
- Experience in preparation of critical submission documentation.
- Experience leading multidisciplinary teams.
- Comprehensive understanding of FDA regulations and ICH guidance, as well as comprehensive experience in the drug development process.
- Expertise in translating regulatory requirements into practical, workable plans.
- Willingness to travel as required within a global work environment.
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