Job Description

Position Overview

The Specialist is responsible for all Regulatory Affairs (RA) submission requirements for their assigned product portfolio as applicable. The Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules. The Specialist is also responsible for other activities (as delegated/assigned by their manager) which may include but are not limited to: review of RA agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with RA requirements, authoring/reviewing Standard Operations Procedures (SOPs), training, communication of safety issues, developing product registration plans and strategies.

Primary Responsibilities

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

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

Assist 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 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 PV 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.

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

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.

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

Identifies and Plans variation, renewal and supplemental marketing authorization using appropriate systems and ensures timely submission

Updates and implements local regulatory procedures in a timely manner

Trains appropriate personnel on regulatory procedures.

Plans and tracks all regulatory actions to document and ensure full compliance with relevant legislation and with internal procedures.

Artwork management system

Provides regulatory insight and strategy to commercial team for new projects

Establishes and develops close interactions with relevant regulatory Authorities and professional associations

Skills (professional and/or technical)

Primary skills include but are not limited to: 1. Collaboration and Partnering: Demonstrates ability to work in partnership with others (internally and externally) to accomplish quality goals. 2. Communication Skills: Demonstrates good communications skills to convey and receive information in English and local language. 3. Problem Solving: Demonstrates good skills in problem solving 4. Project Management: Demonstrates good skills in the ability to organize work efforts, prioritize tasks and utilize appropriate resources to support PV and RA activities in accordance with timelines and appropriate regulations. 5. Decision Making: Demonstrates strong skills to utilize knowledge, networks and data to make rapid and appropriate decisions with management oversight and to determine when escalation of issues is necessary. 6. Regulatory and Compliance Management: Demonstrates knowledge of PV and RA regulations and regulatory trends. 7. Business Operations/Knowledge of Field: Demonstrates knowledge of business trends and applies this knowledge to optimize daily activities and make appropriate decisions that improves the quality of business and functional area outputs. 8. Regulatory and Compliance Management: Demonstrates knowledge of PV and RA regulations and regulatory trends

Experience

The incumbent must have a health, life science, or medical science degree or equivalent by education / experience and be fluent in English (written and spoken) while proficient in local language. He/she should have a minimum of 1 year of industry experience in in pharmacovigilance and/or regulatory affairs. He/she must have a general knowledge of PV/RA regulations within his/her assigned country and be an expert in PV & RA processes/activities.

Education

The incumbent must have a health, life science, or medical science degree or equivalent by education

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.

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at .

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

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

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings: 1

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