What are the responsibilities and job description for the Senior Scientist, Regulatory Affairs - Chemistry, Manufacturing and Controls position at Organon Brasil?
Job Description
The Position
The Sr. Scientist, Regulatory Affairs CMC will implement regulatory Chemistry, Manufacturing, & Controls (CMC) strategies for assigned products in accordance with global regulations, guidance, and defined regulatory strategies. Prepare and review of information required for development of Regulatory CMC dossiers for projects and products including clinical development, original registrations, life-cycle maintenance submissions, and post-approval changes. 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 global regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support global development (IND, IMPD), new registrations (NDA, MAA), post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Ensure product compliance through timely and accurate maintenance of CMC submissions in the systems. Liaise with company's 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 company's Regulatory CMC management, as needed.
Required Education, Experience And Skills
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
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)
$103,100.00 - $175,300.00
Please Note: Pay Ranges are Specific to local market and therefore vary from country to country
Employee Status
Regular
Relocation:
No relocation
VISA Sponsorship
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
Shift
Flexible Work Arrangements:
Valid Driving License
Hazardous Material(s):
Number Of Openings
1
Requisition ID:R532539
The Position
The Sr. Scientist, Regulatory Affairs CMC will implement regulatory Chemistry, Manufacturing, & Controls (CMC) strategies for assigned products in accordance with global regulations, guidance, and defined regulatory strategies. Prepare and review of information required for development of Regulatory CMC dossiers for projects and products including clinical development, original registrations, life-cycle maintenance submissions, and post-approval changes. 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 global regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support global development (IND, IMPD), new registrations (NDA, MAA), post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Ensure product compliance through timely and accurate maintenance of CMC submissions in the systems. Liaise with company's 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 company's Regulatory CMC management, as needed.
Required Education, Experience And Skills
- Must have a Master’s degree in Chemistry, Biochemistry, Chemical Engineering, Biology, Pharmaceutical Sciences, Microbiology, Virology, or Molecular Biology with at least three years overall relevant work experience including three years direct experience in formulation, analytical or chemistry process development OR a Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, Biology, Pharmaceutical Sciences, Microbiology, Virology, or Molecular Biology and at least four years overall relevant work experience including three years direct experience in formulation, analytical or chemistry process development.
- Additionally possess experience in authoring and reviewing of Regulatory CMC related documentation, evaluation of Subject Matter Expert (SME) technical documentation for completeness and sufficient details in order to make accurate regulatory assessments through utilization of current global regulatory guidance, and reviewing of scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
- Must possess familiarity with regulatory guidelines for product development, new registrations, post-approval change management and data requirement.
- Must have demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner; strong listening skills; understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
- Understanding of manufacturing, specification setting and stability protocols related to the pharmaceutical business and understanding of the principles of cGMP.
- 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; and ability to manage multiple projects to ensure on-time deliverables and timely submissions to ensure product supply continuity also required.
- Must have proof of legal authority to work in the United States.
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
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)
$103,100.00 - $175,300.00
Please Note: Pay Ranges are Specific to local market and therefore vary from country to country
Employee Status
Regular
Relocation:
No relocation
VISA Sponsorship
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
Shift
Flexible Work Arrangements:
Valid Driving License
Hazardous Material(s):
Number Of Openings
1
Requisition ID:R532539
Salary : $103,100 - $175,300
