Job Description

The Position

The RAaPV Specialist is responsible for all aspects of regulatory submissions in the assigned markets. Critical to this role is to combine knowledge of scientific and regulatory issues to enable new/established products that are developed, manufactured, or distributed meet the local legislations and company procedures. Leveraging on expertise in regional regulations, Authority expectations and industry trends, this role will collaborate closely with cross-functional teams to enhance regulatory initiatives, drive regulatory compliance, and support supply continuity.

Responsibilities:

Acts as the regulatory relevant License Holder for the company (eg. License To Operate).

Responsible for all regulatory submission requirements for their assigned product portfolio as applicable.

Collaborates with colleagues to ensure compliance with local laws and regulations and company SOPs.

 Assist in development of product registration plans & strategies and working cross-functionally to align & communicate the submission plans.

Support maintenance of authorized products through timely submission of post-market regulatory dossiers, including but not limited to variations, renewal applications, site transfers, importation, distribution, tender related activities and supplemental marketing authorizations in accordance with local regulations and global standards.

Maintain and archive regulatory documents 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.

Assists in improving local procedures (in compliance with regional and global standards) for the department, to ensure quality 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.

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

Ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply-chain.

May serve as the deputy/back-up Qualified Person for PV (QPPV) / Local Responsible PV person as required per local PV legislation and will be responsible for managing local PV activities as assigned.

Coordinate and oversee regulatory activities across the cluster/region for assigned projects, including regulatory and pharmacovigilance submissions and filings.

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:

Requisition ID:R529135