What are the responsibilities and job description for the Senior Manager, Regulatory Affairs - Drug-Device Combination Products position at Stira Pharmaceuticals?
Company Description
Stira Pharmaceuticals,
ocated in Fairfield, NJ,
is a Sterile Injectable CDMO specializing in pharmaceutical product development and manufacturing of small molecules and peptide finished dosage forms. The company's team of skilled scientists uses in-house technology platforms and extensive prior experience to develop challenging products. Stira Pharmaceuticals offers a range of services including Analytical R&D, Preformulation, Formulation Development, Manufacturing, Regulatory Support and more.
Stira Pharmaceuticals is currently seeking a highly motivated Senior Manager in Regulatory Affairs to join our growing team. This is an exciting opportunity for a dynamic individual with expertise in regulatory affairs for drug-device combination products to contribute to the success of our business.
Role Description
This is a full-time on-site role for a
Senior Manager of Regulatory Affairs, you will play a key role in the regulatory strategy and submission activities related to ANDAs and 505(b)(2) applications for sterile injectables, specifically those involving drug-device combinations. This role requires deep knowledge of the regulatory processes, as well as the ability to manage complex projects in a fast-paced environment.
Key Responsibilities :
- Lead regulatory submissions for ANDAs and 505(b)(2) applications for sterile injectable drug-device combination products.
- Provide strategic input on regulatory strategies and filings for combination products, ensuring compliance with FDA regulations and guidances.
- Work closely with cross-functional teams, including R&D, Quality, and Manufacturing, to ensure regulatory requirements are met throughout the development lifecycle.
- Prepare and review regulatory documents, including submission packages, reports, and responses to agency queries.
- Interface with regulatory agencies, primarily the FDA, to ensure clear and timely communication on product development and regulatory requirements.
- Maintain up-to-date knowledge of regulatory trends and requirements impacting drug-device combination products.
Qualifications :
Why Stira Pharmaceuticals?
Stira Pharmaceuticals offers a collaborative work environment with ample opportunities for career growth and development. We are committed to innovation and improving patient outcomes, and we offer competitive compensation and benefits packages
How to Apply :