Job Description
Position Overview
The RA Associate Specialist supports the approval and maintenance of product licenses by assisting with the development of effective registration strategies aligned with domestic regulations and global compliance standards. This role involves managing submission processes, ensuring regulatory compliance, and providing guidance to internal and external teams. Additionally, the Associate Specialist evaluates safety information, supports regulatory operations, and contributes to efficient information management to meet both local and global requirements
Primary Responsibilities
Basic Functions & Responsibility (may not be limited to):
Under the supervision of the Director/Associate Director, prepares, submits, and follows up on Marketing Authorization applications for assigned products to the MFDS (Ministry of Food and Drug Safety) in a timely manner.
Under the supervision of the Director/Associate Director, supports the maintenance of authorized products by timely submission of variations, renewals, RMPs, pre-approval and post-approval GMP audits, and supplemental marketing authorizations for assigned products.
Supports RA projects lead by Specialist/Sr. Specialist under the supervision of the Associate Director.
Ensures high-quality labeling, translation, and artwork management for assigned products.
Supports interactions with the MFDS to ensure smooth submission, assessment, and approval processes.
Stays updated on relevant regulations and guidelines for assigned products and tasks.
Monitors, reviews, and assesses local regulations and regulatory intelligence, sharing relevant updates with stakeholders.
Maintains positive relationships with internal and external regulatory contacts.
Major Activities (may not be limited to):
Maintenance of licenses for assigned products:
Under supervision, ensures marketing authorizations are maintained in compliance with regulatory requirements by performing activities such as variations, renewals, and RMPs within agreed timeframes.
Communicates approvals to stakeholders in alignment with corporate standards and local regulations.
Compliance:
Prepares and maintains local labeling, packaging materials, and other regulatory documents for assigned products according to company and local standards, as well as relevant Artwork Management procedures.
Ensures internal stakeholders receive relevant information regarding the regulatory status of assigned products.
Utilizes the Artwork Management System to generate mock-ups and commercial artwork, implementing revisions as necessary.
Ensures regulatory files and archives are kept up-to-date and complete.
Implements updated regulatory documentation (including CMC and S&E documents) according to MFDS requirements and internal guidelines.
Artwork
Prepares artwork, including package leaflets and all other components, in a timely and accurate manner, and in accordance with the relevant Artwork Management procedures.
Responsible for proofreading packaging components and maintaining up-to-date files on packaging components.
Cross-functional activities
Adequately supports other functions to ensure compliance in areas related to regulatory matters.
Regulatory policy & environment
Continuously stays informed about local and international laws and regulations that impact the work.
Required Education, Experience and Skills
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field.
1-3 years of experience in RA or related fields.
Regulatory Expertise: Basic knowledge of MFDS requirements, submission processes, and compliance standards throughout the product lifecycle.
Problem Solving & Strategic Thinking: Ability to evaluate regulatory impacts and develop effective strategies for approvals.
Attention to Detail & Accuracy: Strong skills in reviewing regulatory documents, labeling, and artwork to ensure compliance with quality and accuracy standards.
Collaboration & Communication: Effective interpersonal and communication skills to work with cross-functional teams and regulatory authorities.
Project Management: Ability to handle multiple tasks while adhering to regulatory requirements and internal procedures.
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 relocationVISA 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