Sr. Scientist, Regulatory Affairs

Job Description

The Position  

Reporting to the CMC Principal Scientist, International CMC (LATAM), the successful candidate will be responsible for assessment of changes for regulatory impact, development of regional CMC strategy, preparation of CMC documentation and execution of regional post-approval CMC supplements and new product registrations for the entire Organon portfolio of small molecule, biologic and biosimilars, serving as a link between Country Regulatory Affairs (CRA) team requirements and global CMC strategy to ensure right first-time submissions to Health Authorities. He/she will work closely with CMC Product Leads to ensure that Organon's key CMC projects are successfully prosecuted in the region.

Appointment to this position will be on local salary and benefits package.

Responsibilities  

The incumbent will be accountable for implementing regional CMC strategy for international markets for post-approval CMC supplements and new product submissions with a focus on achieving right-first-time submissions, including the following activities:

For assigned product portfolio, develop robust CMC regional regulatory strategies for new marketing applications, Scientific Advice and post-approval changes, as appropriate.

Working collaboratively with Global CMC RA Product Leads, the team will ensure right first-time submissions, high approval rates, on target launches and successful implementation to maintain patient supplies throughout the product lifecycle.

Ensure that the regional CMC regulatory strategy is aligned with the global regulatory strategy, Franchise portfolio, commercial and operational strategies and issues impacting product approval, launch or patient supplies will be appropriately escalated to CMC Regulatory Affairs Management.

Support Organon Country RA affiliate interactions with their local Regulatory Agencies to facilitate Scientific Advice and the prompt review and approval of submissions (as CMC content subject matter expert). 

Act as Regulatory CMC SME in regional post approval requirements, ensure awareness of regional regulatory policy trends and maintain/update the regulatory intelligence repository for regional markets, including communicating proactively with Global CMC Product Leads on regional registration requirements, new legislation and guidance and providing timely update of the CMC change management systems to support right first-time submissions.

Ensure high quality and timely responses to Regulatory Agency questions in regional markets and fulfillment of regulatory commitments to Regulatory Agency deadlines.

Support product compliance by ensuring local registrations and lifecycle management align with product manufacturing details.

Drive continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice.

Influence CMC initiatives by internal and external engagement including trade associations and regulators to pursue priority advocacy plans impacting the business.

 Required Education, Experience and Skills  

The candidate must possess a Bachelor's or Master's Degree in chemistry, pharmacy, biology or a related science, with a minimum of 4 years of experience in the pharmaceutical industry, in Regulatory Affairs and/or Technical Regulatory.

The ideal candidate will have experience in Regulatory Affairs for the regional markets, with a focus on Regulatory CMC requirements for small molecule/biologic/biosimilar products, development, manufacturing and/or quality assurance. Direct Health Authority experience would be an advantage.

He/she will demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks.

Preferred Education, Experience and Skills   

Must have a proven ability to communicate effectively in both a written and verbal format. The ideal candidate will be fluent in 1-2 languages spoken in the region of responsibility, in addition to English.

Ability to influence and work both independently and collaboratively in a team structure.

Proven ability to work well under pressure.

OCMC

Secondary Job Description

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.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. 

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. 

Annualized Salary Range

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:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings: