Sr. Spclst, Regulatory Affairs

Job Description

Responsible for execution of local RA processes and activities in alignment withRA systems and their associated Quality Management System, followingdepartment SOPs, company Policies and Procedures and country legislation.

Assists in development of product registration plans & strategies and working cross-functionally to review & communicate the registration strategy with management oversight.

Assists in timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers, including but not limited to variations, renewal applications and supplemental marketing authorizations in accordance with local regulations and global standards.

Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.

Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.

Supports local RA audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations.

Participates in and supports audits of contractual partners/vendors as necessary.

May be trained and assigned responsibility to conduct qualification and ongoing audits of vendors and perform due diligence activities for local country licensing agreements.

Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality of the RA data and evaluates processes for potential improvement in efficiency and effectiveness.

Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.

Supports training of the local company staff, distributors, vendors, business partners including training documentation.

Contributes in the maintenance of regulatory licenses including, but not limited to, import, distribution, Medical Device.

May be assigned to support drug shortage management and regulatory requirements for reporting including collaborating with Head Quality Assurance to avoid supply constraints and ensure constant audit-readiness.

May be assigned responsibility for ensuring appropriate implementation and oversight of local Risk Minimization Measures.

Liaises with the local business units to keep them informed of safety activities and provide input on strategic decisions (i.e., new clinical trials, product launches, etc.) with Management oversight.

May be assigned responsibility for any RA related Projects.

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:

Temporary (Fixed Term)

Relocation:

No 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:

1