Job Description
The Position
Under the direction of the Regulatory & PV Lead/Senior Regulatory Specialist, the incumbent:
Executes regulatory activities for products in order to get products to market according to company plans.
Handles timely submission and follow-up of labeling & CMC variations and GMP submissions.
Ensures permanent compliance to local regulatory requirements and to Organon’s policies and procedures.
Demonstrates clear leadership in shaping the regulatory environment to support company objectives.
Keeps abreast on regulatory environment evolution and challenges, provides advice on resulting strategy.
Ensures that local Quality activities are completed according to company Quality Systems and all legal requirements are met.
Responsibilities
Maintenance of existing products (`)
Ensures timely submission and follow-up of both labeling and quality-related variations to the marketing authorizations and GMP related submissions, in cooperation with the key stakeholders.
Manages the renewal process in liaison with the HQs, ensuring that the renewal files are prepared, submitted and approved in due time.
Ensures timely and proper submissions for license transfers of related products Handles the control of packaging components artworks developed by labeling coordinator.
Works in close collaboration with Labeling Coordinator for the artworks’ approval process and the follow-up of the printing process to ensure proper implementation of artworks changes.
Coordination and close follow-up with local partners.
This role will be a one-year contract role as a project based.
The candidate will be working directly with global team as well as Turkey local team.
Regulatory Compliance (%)
Updates and implements local regulatory procedures in a timely manner, in close synergy with the regional organization.
Adapts new regulatory procedures to his/her job.
Plans and tracks all regulatory actions to document and ensure full compliance with relevant legislation and with internal procedures.
Coordination and close follow-up with local partners
Updates local and global systems frequently.
Shape regulatory environment ()
Pro-actively shares intelligence on competitive products, generics/copies, as well as on emerging regulations.
Interacts with Ministry of Health when needed.
Keeps abreast of trends and legislation, at both national and international levels.
Provides advice and recommendations to Management and to regional organization on regulatory policy and applicable strategy in order to accelerate regulatory approvals while securing compliance.
Required Education, Experience and Skills
Bachelor's degree in pharmacy (preferred), Chemistry, Chemical Engineering
Up to 2 years of experience in Regulatory Affairs in similar position
English Fluency
Leadership competencies
Strategic thinking and proactive management capability
Collaboration and active communication
High sense of customer orientation
High sense of collaboration
Advanced negotiation skills
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: