The Manager, Regulatory Affairs - Innovative (MRAI) will represent the Regulatory Affairs – Innovative function on global project teams developing candidates from Glenmark’s innovative portfolio of biologics and small molecules. The MRAI will support the global regulatory project lead as well as independently coordinate, compile and produce routine regulatory submissions/amendments (IND/NDA). This position will interface with multiple research and operational functions located around the world (e.g., clinical, nonclinical/pharmacology, manufacturing, quality, biostatistics, pharmacovigilance, etc.) and will provide regulatory expertise on questions/issues that arise during product development.
The primary focus for this position will be the U.S. FDA; however, the MRAI will be required to support the registration activities of Glenmark’s innovative candidates outside of the U.S.
Support the global regulatory lead in the implementation and development of innovative regulatory strategies for assigned projects with the objectives of successful development and timely registration.
Planning, writing, compiling and/or reviewing routine regulatory submissions (annual reports, amendments, etc.) to support ongoing research and product registration activities.
Serve as the back-up for the lead Regulatory Affairs (RA) representative on the Product Development Team.
Track timelines on regulatory deliverables and provide periodic updates on the status of development projects. The MRAI will be responsible for identifying and escalating, as appropriate, issues that may impact the timely achievement of corporate goals.
Serve as the US regulatory representative on the Global Regulatory Functional Team which collectively will have overall responsibility for management of global regulatory regulatory submissions for the project with assigned/contract regional regulatory support.
Reviewing manufacturing/quality change controls and assessing the scope/impact of the change(s) and the appropriate means for implementing the change.
Ensure that all regulatory submission documents are fully compliant with internal document standards for format and content and that appropriate quality reviews have been performed.
Ensure sound regulatory practices are fully integrated in all pre-clinical, clinical and technical submissions, and evaluate all documents submitted to the FDA to ensure they are complete, well organized, scientifically accurate, of high quality, in regulatory compliance and presented in a manner that facilitates agency review.
- Bachelor’s degree is required with a Master’s degree or higher (PhD, PharmD) preferred plus appropriate level of pharmaceutical industry and regulatory affairs experience.
- 5+ years of regulatory experience in the biotech/pharmaceutical industry; experience in the oncology/immunology and respiratory therapeutic areas is a plus.
- Practical experience with biologics and small molecules, as well as experience dealing with multiple aspects of regulatory affairs (CMC, clinical, nonclinical) is strongly preferred.
- Previous experience in leading submission teams for marketing and/or clinical trial applications is desired.
- Full functional knowledge of US regulatory requirements pertaining to the development and registration of biological drug products
- Experience with IND and NDA filings required
- Working and/or in depth knowledge of clinical and CMC aspects of regulatory affairs
- Extensive experience with the electronic Common Technical Document (eCTD) format
- High-level proficiency with MS Word templates and/or formatting functionality
- Proficiency with MS Excel
- Knowledge of EU clinical trial/registration dossiers desirable
- Proven ability to manage complex projects
- Outstanding written/verbal communication skills, good interpersonal skills and familiarity with Microsoft Office and Adobe Acrobat applications
- Excellent attention to detail and problem solving skills