Location: Edison NJ & Various Unanticipated Locations throughout The U.S.
- Independently execute activities related to maintaining compliant Regulatory status for marketed products portfolio including annual reporting, change control management, Supplement filing (CBE-30, CBE-0, PAS), response to deficiency letters, and compliance gap closures.
- Prepare, author, review, coordinate and manage CMC regulatory submissions, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance.
- Serve as functional CMC representative on assigned New Product Development teams and related technical task forces as well as Lifecycle management projects such as site transfers.
- Effectively manage the preparation of CMC regulatory submission documents, including for clinical trial applications, marketing applications, post-market changes, and scientific advice in adherence with applicable regulations and guidelines for submission to health authorities.
- Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs. Provide Technical Guidance to the development and implementation of clinical, pre-clinical and CMC regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial)
- Perform project management on larger submission projects (new NDAs, INDs, NDSs, CTAs, supplements, etc.) by developing and maintaining detailed submission timelines, incumbent will translate the regulatory strategy into realistic and executable regulatory deliverables with clear assumptions.
- Review of the dossier to identify potential GAP and coordinate with Cross Functional teams to close the identified GAPs and identify the CMC data requirements for the Immunogenicity assessment of the complex drug products.
- Compile and complete high quality ANDAs and Amendments ensuring final submission meet requirements of ANDA checklist recommended by USFSDA to avoid any acceptance to file issues. Ensure all submissions and projects are completed with the expected timeline. Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.
- Managing Regulatory Information Management (RIM) process for tracking Drug Product Registrations Worldwide, including Registration Status, Variations, Health Authority Correspondences, and Commitments.
- Masters’ degree in Bio Medical/Life Sciences.
- Special knowledge or skills needed and/or licenses or certificates required.
- Prior experience within a GMP environment with a firm understanding of industry regulations and best practices
- Good working knowledge of the FDA, EMEA and ICH regulations and guidance's for CMC.
- Knowledge of global regulatory guidance's as they relate to the overall global regulatory strategy.
- Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
- Thorough knowledge of the drug development process, with a focus on the regulatory CMC processes.
- Demonstrated experience in preparing IND and/or NDA submissions.
- Proficiency with Microsoft Office, Veeva Vault, eCTD Manager, Trackwise and other EDMS systems.
- Excellent verbal and written communication and skills.
- Ability to work collaboratively under supervision, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Mail resume with cover letter to AM Logic Corporation, 3830 Park Avenue, Suite 207, Edison, NJ 08820; Job 17AMC01; EOE