Senior Scientist, Regulatory Affairs - Chemistry Manufacturing & Controls (CMC)

Organon; Florham Park (NJ); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Organon is seeking a Senior Scientist to implement Regulatory CMC strategies for assigned products in the United States. The role involves preparing and reviewing information for regulatory CMC dossiers for development and post-approval activities, with a strong emphasis on global regulatory conformance.

The candidate will lead CMC submission components, assess risks, and liaise with Manufacturing & Supply and external partners to ensure compliant change management.

Qualifications

• Bachelor’s degree with at least 4 years relevant experience.
• Advanced degree with at least 2 years relevant experience.
• Direct experience in Regulatory CMC preferred.
• Proficient in English; additional language skills a plus.
• Strong communication and leadership skills.

Responsibilities

• Input to global regulatory strategies by assessing CMC changes and identifying global regulatory requirements.
• Lead development, authoring and review of CMC submission components.
• Coordinate with Manufacturing & Supply and partners for compliant change management.
• Assess regulatory risks and propose mitigation strategies.
• Deliver regulatory milestones across the product lifecycle.
• Identify and communicate regulatory issues to Organon Regulatory CMC management as needed.

Skills

Regulatory CMC knowledge

English proficiency

Scientific writing

Stakeholder communication

Project leadership

Education

Bachelor’s degree in science/engineering

Advanced degree (MS/PhD/MBA/PharmD)

Job description

The Position

The Senior Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products in accordance with global regulations, guidances and defined regulatory strategies. The Senior Scientist is responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products.

Responsibilities

• Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
• Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
• Liaise with Organon Manufacturing & Supply colleagues and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
• Assess and communicate potential regulatory risks and propose mitigation strategies.
• Deliver all regulatory milestones for assigned products across the product lifecycle
• Identify and communicate potential regulatory issues to Organon Regulatory CMC management, as needed

Required Education, Experience & Skills

• Bachelor’s Degree, in a science, engineering,or a related field. Fields of study includePharmacy, Chemical Engineering,Biology,Microbiology, Virology, Molecular Biology, or Biochemistrywith at least 4 years of relevant experience including biological/pharmaceutical research, manufacturing,testingor a related field OR
• Advanced degree (MS, MBA, Ph.D., PharmD) with at least 2 years of relevant experience including biological/pharmaceutical research, manufacturing,testingor a related field
• Direct experience in Regulatory CMC is preferred
• The candidate must be proficient in English; additional language skills are a plus.
• Experience in reviewing 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 oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
• Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
• Demonstrated ability to generateinnovative solutions to problems and effectively work with and communicate to key stakeholders.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Capability to handle multiple priorities and balance work to achieve business goals.
• Demonstrated effective leadership, communication, and interpersonal skills.

Please note, relocation assistance is not provided for this position.

Organon

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.

Equal Employment Opportunity

Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.

Search Firm Representatives Please Read Carefully

Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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.

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

Number of Openings

1

Requisition ID

R543249