The primary role of this position is to support the filing of Original ANDAs (505j) and NDAs (505b2) applications to the US FDA for sterile, injectable drug products. This includes responding to FDA IR, DRLs and CRLs up to and through approval of the application. The successful candidate will need to work closely with management, consultants and the manufacturing sites to accomplish these goals. The position may or may not have direct reports and traveling is infrequent.
- The candidate should have complete knowledge and experience with submitting original ANDA 505(j) and NDA 505(b)(2) applications for sterile injectable drug products to the US FDA including complex injectables and combination drug products. Communication with the FDA either in person, by telephone or written response letters is required. Notify management concerning FDA communications and application status and document these communications.
- Attend internal and external meetings, as needed, to provide the necessary regulatory strategy. Follow-up as necessary.
- Interpreting CFR (laws) and FDA/ICH guidance(s) applicable to the development and operations of ANDA and NDA, and to support the rollout and communication of these regulations within the R&D organization as well as manufacturing sites.
- Communicate regulatory strategy and implementation plan for submissions as well as submitting timely controlled correspondence(s) to the FDA to support critical research & development.
- Lead the team to create a robust FDA meeting package to assist in successful FDA Development and/or pre-ANDA / IND meetings including but not limited to bioequivalence strategy (bridging studies), critical testing requirements and specifications, as applicable.
- Review application documents needed to file and ensure compliance with all pertinent e-CTD modular sections and subsections for Module 1, Module 2, Module 3, Module 4 and Module 5, as applicable, including but not limited to: labeling, DMF(s), PDR(s), formulation(s), manufacturer(s) information/process, specification(s), justification of specification(s), methods/validations, batch records, sterility validation packages, stability protocols/commitment/data, toxicology reports and clinical study reports.
- The candidate should have comprehensive knowledge of regulatory guidelines and statutes including: CFR, FDA & ICH Guidelines, FDA Recommended BE Drug Product Specific Guidance, and USP compendia general chapters for all sterile injectable dosage forms including combination drug product guidelines, as applicable. The candidate is responsible for communicating this information and new information/changes to the project team(s) and department on a timely basis.
- The candidate should have knowledge pertinent to the requirements for the creation and maintenance of site design history files including: a complete risk assessment, inputs, outputs, design and specifications of the device needed for combination drug products and human factor study regulations in order to ensure sufficient similarity of the device when compared to the RLD.
- The candidate should have complete knowledge of extractable/leachable, elemental impurity, and genotoxic impurity regulations as defined in the USP, ICH and FDA regulations including PDE calculations.
- This position requires timely communication, feedback and follow-up with the FDA and management.
- This role is responsible for maintaining open communication with management, consultants, employees within the company and manufacturing sites.
- This position is mainly responsible for pre-approval regulatory affairs activity but will need strong knowledge of post-approval regulatory affairs for those products developed in R&D that require a post-approval submission. Management of workload and duties - including close collaboration with project management, mentoring and training RA staff, and ensuring the best outcome for filing-to-approval timelines/cycles are met.
- Provide support for due diligence activities associated with business development as required.
- Responsible for overseeing databases such as list of approved products, currently manufactured products, approved manufacturers and suppliers of active ingredient, tracking systems for submissions status as well as periodic reports.
- Perform other duties as assigned.
- Expertise in Pharmaceutical Regulatory and FDA process and interface. Knowledge of FD&C Acts, Title 21 CFR 312, 314, 210, 211 and 820, other current related regulations, and FDA guidelines, is required. Experience with submissions, ANDA and NDAs. Working experience in clinical/bioequivalence studies.
- A history of interaction with the OGD Divisions of the FDA as well.
- B.S. or M.S. in Pharmaceutical, Chemistry or Biological Sciences.
- Minimum of 10 years in regulatory affairs with progressive management experience that includes completing multiple regulatory ANDA(505j) & NDA (505b2) applications/filings.
- Due to the pandemic, the position will initially be remote until we can return to the office based in New York, NY with the possibility of full-time remote.
Pyros is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.
Pyros Pharmaceuticals develops high-quality, proprietary and off-patent pharmaceuticals for the US market. Research and development are the cornerstones of our growth strategy. Providing quality products through scientific innovations, diligence and precision is the goal of all of Pyros’ research programs. We explore a broad range of therapeutic areas that have technically challenging drug delivery mechanisms or other niches, including products with the potential for six months of exclusivity for being first-to-file or first-to-market. Our goal is to create a broad portfolio of limited source branded and generic pharmaceutical products that will provide high-quality, affordable and accessible alternatives.
Job Type: Full-time
- Dental Insurance
- Disability Insurance
- Flexible Schedule
- Health Insurance
- Life Insurance
- Paid Time Off
- Vision Insurance
- regulatory affairs: 10 years (Required)
- Have you directly been involved in preparation and submission of Abbreviated New Drug Applications (ANDA)?
- One location
- Multiple locations
- Fully Remote
- Only full-time employees eligible