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

9000 Organon LLC; Florham Park (NJ); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Retirement savings plan

Paid vacation and holidays

Parental leave and medical leave

Comprehensive health benefits

Job summary

Organon is seeking a Senior Scientist to implement Regulatory CMC strategies for small molecules or biologics, ensuring alignment with global regulations and strategies.

You will prepare and review information for regulatory CMC dossiers, lead development, authoring and review of submission components, and drive milestones across the product lifecycle in a collaborative, cross-functional environment.

Qualifications

• Bachelor’s degree in science/engineering or related field with relevant experience.
• Advanced degree plus experience in regulatory CMC preferred.
• Proficient English; additional languages a plus.

Responsibilities

• Provide input to global regulatory strategies and assess regulatory requirements.
• Lead development, authoring and review of CMC submission components.
• Coordinate with manufacturing and external partners for change management.
• Assess risks and communicate mitigation strategies; deliver milestones.

Skills

Regulatory CMC experience

English proficiency

Leadership

Project management

Strong communication

Education

Bachelor’s Degree in science/engineering/related field

Advanced degree (MS, MBA, Ph.D., PharmD)

Job description

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.

Benefits

• 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

• Annualized Salary Range (US)
• 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 and Requirements

• 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.

Work Arrangements and Openings

• 10% Flexible Work Arrangements: Flex Time, Hybrid Shift
• Valid Driving License
• Hazardous Material(s)
• Number of Openings: 1

US and PR Residents 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.

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. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement OFCCP Pay Transparency Rule

At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.