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

The Position

Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal Scientist (Associate Director) is responsible for Regulatory Chemistry Manufacturing & Controls (CMC) aspects of clinical phase through market product registration for the assigned portfolio of small molecule, biologic, biosimilar and/or combination products which are acquired or licensed externally as a key component of the company growth strategy. The organization is envisioned to focus on innovative products addressing women’s health across diverse therapeutics including Biosimilars and will encompass late-stage development products and commercially approved compounds. The Associate Principal Scientist may also support project team goals and organizational initiatives, on an as needed basis. Primary responsibilities include, but are not limited to:

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. This includes documenting regulatory CMC strategies, leading preparation and authorship of applicable IND/CTAs, 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. This role will directly support projects and/or coordinate with Regulatory CMC scientists in the Organon franchise teams.
• 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.
• 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.

Required Education, Experience and Skills

• 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 4 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field.
• Direct experience in Regulatory CMC is preferred.
• At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, analytical testing; or related fields.
• 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.

Preferred Experience and Skills

• 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.

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.