Posts classified under: Regulatory Affairs

Company Overview

Pyros Pharmaceuticals develops high-quality, proprietary specialty pharmaceuticals for rare diseases with high unmet needs. Research and development are the cornerstones of our growth strategy. Providing quality products through scientific innovations and precision medicine is the goal of all of Pyros’ research programs.

Role Summary

The Regulatory Affairs CMC Senior Associate, reporting to the Regulatory Affairs CMC Manager, manages simple to moderately complex submission projects. This individual will be responsible for helping create and maintain regulatory systems capable of supporting IND, NDA, and ANDA submissions as well as collaborating with outside manufacturing/development partners to create scientifically sound, high-quality submission documents, as well as facilitate strategic submission team meetings. This position will require significant hands-on activity to support our growing pipeline.

Responsibilities

  • Prepare CMC sections in IND, NDA, and ANDA regulatory applications in eCTD format for FDA submission in compliance with required timelines, specifications, and guidelines.

  • Coordinate resolution to any deficiencies and questions from the FDA regarding products, including determining strategy, document preparation and coordinating the completion of any special testing requests. Individual will be accountable to ensure submission dates are achieved.

  • Assist in the development and maintenance of processes, templates, and standards for ANDA, NDA, and IND submissions.

  • Independently prepare all submission types including ANDAs, NDAs, INDs, and associated amendments and supplements in compliance with current FDA requirements.

  • Collaborate with project team members to obtain and prepare required submission documents.

  • Review compiled submissions prior to being sent to Agency.

  • Identify process improvements to gain efficiency and meet Right First-Time objectives.

  • Mentor Labeling and development partners in CMC requirements to support the business.

  • Review, interpret, and ensure compliance with current FDA and ICH guidelines, as well as compendial standards to ensure compliance with those requirements.

  • Effectively manage multiple projects and competing priorities.

  • Other duties as assigned.


Skills & Requirements

  • Broad knowledge of FDA manufacturing and testing expectations for a wide variety of dosage forms. Experience with special requirements for sterile product submissions is desirable.

  • Ability to handle multiple projects simultaneously and work in a fast-paced environment to meet deadlines and mitigate emergencies.

  • Excellent communication, negotiation, and interpersonal skills; able to discuss issues and ideas with internal and external partners with an open mind and even temper, while maintaining confidentiality as the situation requires.

  • Strong continuous improvement mindset and able to perform duties which are non-standardized and require the ability to adapt to change.

  • Able to work independently or in a team and collaborate with employees at all levels.

  • High attention to detail, and strong decision-making skills.


Qualifications

  • Bachelor’s degree in a scientific field such as chemistry, microbiology, or pharmaceutics.

  • At least 5 years’ experience in Regulatory Affairs with experience with FDA submission requirements for products.


Apply


Submit your resume below or send your resume to [email protected].

 

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.