The Role
Lead regulatory strategy and interactions with FDA and other authorities for development programs. Manage preparation, review, and submission of INDs, BLAs/MAAs, CTAs, and related amendments; provide regulatory guidance to multidisciplinary teams; review clinical and nonclinical data and protocols; ensure submission completeness; supervise regulatory submission planning and staff.
Summary Generated by Built In
Responsibilities
- Act as liaison between company and FDA and other health authorities for assigned programsDevelop regulatory strategies for assigned programs, in order to support Company’s development and marketing objectives. This will be achieved through analysis of guidance’s and assessment of other drugs, and in collaboration with Company's regulatory senior management. Management of regulatory activities associated with Company development programs.
- Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals.
- Provide guidance to multidisciplinary teams on the content, format, style and architecture of an Investigational New Drug (IND) application or CTA for ex-US studies. Edit or manage the editing of scientific sections of regulatory documentation against the regulatory requirements. Assist with the writing, review and preparation of an IND application. Manage the organization, preparation and review of IND amendments, annual reports and other regulatory documents and correspondence.
- Perform/manage critical analyses of data (clinical, preclinical and manufacturing), independently developing interpretations and conclusions.
- Perform reviews of clinical protocols and study reports to focus attention on deficient/missing items/explanations.
- Accountable for ensuring the completeness and accuracy of all regulatory submissions.
- Supervisory responsibility for the planning, preparation and submission of regulatory documentation.
- Management of the planning, preparation and submission process for licensing applications.
- Provide guidance/instruction to multidisciplinary teams on the content, format, style architecture and timing of a Biologics Licensing Application (BLA) or MAA and the subsequent regulatory review process.
- Assist with the scientific writing and review of a BLA and evaluate conformance with the regulatory requirements.
- Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements for scientific staff as required.
Requirements
- Requires an advanced technical degree in life sciences
- Expert knowledge of regional health authority regulations and advanced knowledge of global regulations
- Demonstrated interactions with local health authorities
- Excellent communication skills (verbal and written) and strong analytical skills
- Demonstrated leadership and project management skills, including cross-functional communication
- Education: Ph.D., PharmD, or MD
- At least 5+ years of RA experience and biomedical research
Skills Required
- Advanced technical degree in life sciences (Ph.D., PharmD, or MD)
- At least 5+ years of regulatory affairs experience and biomedical research
- Expert knowledge of regional health authority regulations and advanced knowledge of global regulations
- Demonstrated interactions with local health authorities
- Experience preparing and reviewing regulatory submissions (IND, CTA, BLA, MAA) and amendments
- Excellent verbal and written communication skills and strong analytical skills
- Demonstrated leadership and project management skills, including cross-functional communication
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The Company
What We Do
KMR Search Group is an executive search and recruitment firm specializing in the Healthcare, Pharmaceutical, Biotech, and IT Services industries. Operating with a nationwide reach, they help companies identify and place top-tier leadership talent in specialized roles, as seen in their history of conducting high-level searches for positions such as General Managers and Chief Financial Officers across various industrial sectors.
