Job Description
The Position
TheSenior Scientistis responsible for implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies forassigned small molecule or biological productsin accordance withglobalregulations,guidancesand defined regulatory strategies. The Senior Scientist is responsible for the preparation and review of information required for development of regulatory CMCdossiersforcommercialproducts.
Responsibilities
- Provide input to global product and projectregulatorystrategies byperformingassessments ofCMC changes, identifying global regulatory requirements and critically evaluating supporting documentationto assess acceptability and identify potential risks.
- Execute regulatory strategies by leading thedevelopment, authoring and review of CMC submission components and documentation to supportpost-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 compliantexecution of change management and conduct all activities with anunwavering focus on regulatory conformance.
- Assess and communicate potential regulatory risks andpropose mitigation strategies.
- Deliverallregulatory milestones forassignedproductsacross theproduct lifecycle
- Identify and communicate potential regulatory issues to Organon Regulatory CMC management, as needed
0
Required Education, Experience & Skills
- Bachelors 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 assesstechnicalmerits and suitability of scientific rationale to ensure information ispresented clearly and conclusions are adequately supported by data.
- Demonstrated oral and written communication skillsand theability to communicate issues in a succinct and logical manner. Strong listening skills.
- Demonstrated understanding of related fields (e.g.,pharmaceuticalmanufacturing, analyticaltesting,and qualityassurance).
- 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,andinterpersonal skills.
Please note, relocation assistance is not provided for this position.
OCMC
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)
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
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
