Implement Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for small molecule or biological products in accordance with global regulations, guidances and defined regulatory strategies. Prepare and review information required for development of regulatory CMC dossiers for commercial products. Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting docu... more details
Job Description
The Position
Responsibilities
Implement Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for small molecule or biological products in accordance with global regulations, guidances and defined regulatory strategies.
Prepare and review information required for development of regulatory CMC dossiers for commercial products.
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 and Skills
Must have a Master's degree in Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, Biochemistry or Regulatory Affairs and at least two (2) years of relevant experience that includes experience in biological/pharmaceutical research, manufacturing and testing or a Bachelor's degree in Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, Biochemistry or Regulatory Affairs and at least four (4) years of relevant experience that includes experience in biological/pharmaceutical research, manufacturing and testing.
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 also required.
Must also possess demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner; strong listening skills; and demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
Demonstrated ability to generate innovative 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; and demonstrated effective leadership, communication, and interpersonal skills, also required.
Telecommuting permitted.
Must have proof of legal authority to work in the United States.
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.
US and PR Residents Only
If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants 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.
Annualized Salary Range (US)
$101,900.00 - $173,300.00
Please Note: Pay Ranges are Specific to local market and therefore vary from country to country
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Yes
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, Telecommuting
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
