A. Primary Duties (60%)
- Manage and/or author the preparation, compilation, and submission of CMC sections of original submissions (ex. CTAs, INDs, BLAs, MAAs), required forms (1571, 356h, etc), amendments, supplements, annual reports, control documents, etc. to health authorities.
- Work intimately with functional areas/CROs throughout the drug development process to ensure compliance with all CMC regulatory requirements.
- Formulate CMC regulatory strategy and tactics for all assigned projects and regulatory submissions. Evaluate changes to regulatory documents and formulate a strategy to ensure proper filing categories.
- Ensure that the CMC regulatory requirements are met for associated documents such as clinical protocols, Investigator Brochure, labeling, etc.
- Maintain full awareness of all CMC regulatory activities on assigned projects to assure that the project deadlines and performance standards for these projects are established and met.
- Interface with the FDA and other health authorities, as appropriate to facilitate acceptance/approval of the CMC content of regulatory submissions. Coordinate with appropriate personnel and departments to resolve any regulatory questions or filing issues.
- Act as primary contact/liaison representing Regulatory Affairs with health authorities, internal functional areas, contract customers, and partners as assigned.
B. Secondary Duties (30%)
- Keep current with the FDA/ICH and other pertinent health authority regulations pertaining to CMC guidance for biosimilar, innovator and regulatory filing requirements by independent learning, attending conferences and symposia.
- Collaborate with technical SMEs, Quality Assurance, and other operation functions to develop strong CMC regulatory strategies and assure regulatory compliance with documentation.
C. Culture (10%)
- Foster a strong cross departmental team interactive culture.
- Support business development and strategies activities as required.
- Support solutions for new innovation and collaboration with peersin ONS departments.
- Follow all company best practices to minimize cost and meet budgetary requirements while maintaining commitment to quality.
- Minimum Bachelor degree in scientific discipline (Chemistry, Pharmacy, Biology, etc.).
- 5-10 years relevant pharmaceutical experience
- Understand the drug development process especially CMC development requirements.
- Demonstrated track record of leading/managing positive health authority interactions and submissions.
- Knowledge of global (US, EU, etc.) CMC regulatory requirements for biologics and combination drug products a plus.
- Knowledge and expertise in preparation of CTAs, INDs, and NDAs (BLAs).
- Ability to support and effectively multi-task different and complex assignments and responsibilities.
- Understand, identify, mitigate, and communicate risks at the study or program level.
- Strong oral and written communication skills.
- Proficiency in computer applications such as Microsoft Word, Excel, and PowerPoint.