Job Description

Reporting to the Director in Organon Regulatory CMC, 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 biological/ biosimilar/medical devices/combination products in accordance with global regulations, guidance's and defined regulatory strategies. These products may be internal or acquired or licensed externally as a key component of the company growth strategy. The Associate Principal Scientist will be responsible for the preparation and review of information required for development of regulatory CMC dossiers for new product and/or commercial products including original registrations, life-cycle maintenance submissions, and post-approval changes. The organization is envisioned to focus on innnovative products addressing women's health across diverse therapeutics including Biosimilars and will encompass late-stage development products and commercially approved compouds. 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:

Although one or more potential candidates for this position have been identified, we will consider applications from any interested applicants."

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. 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.
• 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

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 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.

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.

Secondary Language(s) Job Description

Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

$125,400.00 - $213,100.00

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
10%

Flexible Work Arrangements:
Flex Time, Hybrid, Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:
1