Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing & Controls (CMC)

Organon • Plymouth Meeting, PA

1d • $125,400 - $213,100 • Hybrid

About The Position

Organon is a Women’s Health Company dedicated to redefining the future of women’s health by delivering impactful medicines and solutions. The Associate Principal Scientist (Associate Director) in Organon Regulatory CMC is responsible for the Regulatory Chemistry Manufacturing & Controls (CMC) aspects of clinical phase through market product registration for assigned biological/biosimilar/medical devices/combination products. This role involves preparing and reviewing information for regulatory CMC dossiers for new and commercial products, including original registrations, life-cycle maintenance submissions, and post-approval changes. The organization focuses on innovative products for women's health, including biosimilars, late-stage development products, and commercially approved compounds. The Associate Principal Scientist may also support project team goals and organizational initiatives as needed.

Requirements

• Bachelor’s degree, in a science, engineering, or a related field. Fields of study include Pharmacy, Chemistry, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry with at least 7 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field OR Advanced degree (MS, MBA, Ph.D., PharmD) with at least 5 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field.
• Direct experience in Regulatory CMC is preferred with preference for experience in Combination Products.
• The candidate must be proficient in English; additional language skills are a plus.
• Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
• Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Demonstrated effective leadership, communication, interpersonal and negotiating skills.
• Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.

Nice To Haves

• A candidate with experience in Regulatory CMC with demonstrated understanding of related pharmaceutical, biological or device operations (e.g., manufacturing, process development, analytical, and quality assurance) is preferred.
• Secondary Language(s)

Responsibilities

• Partner with Research & Development, Manufacturing & Supply, Business Development and Commercial to embed an adaptable process with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and initial product registration activities in an efficient, agile manner.
• Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse late-stage development and/or licensed in products/medical devices/combination products. This includes documenting regulatory CMC strategies, leading preparation and authorship of applicable IND/CTAs/NDA/BLA and post-approval activities, Health Authority Regulatory CMC engagement strategy, Agency Background Packages, participating in Agency meetings on CMC topics, and executing global initial marketing applications with a line of sight to long-term robust supply.
• Lead development and execution of regulatory CMC strategies to ensure high quality, accuracy, and high likelihood of approval of all regulatory submissions. This includes assessing CMC changes during development and defining regulatory CMC requirements, demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, utilizing regulatory intelligence, and incorporating knowledge of the changing regulatory environment.
• Embed regulatory CMC activities within product development plans that outlines the requirements for the product, the development plan and associated regulatory approval timeline and how this will be managed.
• Support regulatory activities of medical devices in combination with medicinal products.
• Responsible to ensure regulatory requirements are met and systems/processes are executed in a manner to provide visibility to accurate regulatory information to enable proper product control. Ensures appropriate reviews, approvals and systems are in place to maintain the quality of scientific, technical and regulatory information within CMC submissions, responses and correspondence.
• Identify, communicate, and escalate potential regulatory issues to Organon Regulatory CMC management, as needed.

Benefits

• retirement savings plan
• paid vacation and holiday time
• paid caregiver/parental and medical leave
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior