Job Description
The Position
The RA Sr. Specialist ensures timely regulatory approval and product license maintenance by developing effective registration strategies that align with local regulations and global compliance standards. They manage the submission process, maintain compliance with regulatory requirements, and support cross-functional teams by providing regulatory guidance. Additionally, the role involves evaluating safety information, managing regulatory operations, and ensuring efficient information management across the RA area to meet both local and global standards.
Note
해당 포지션은 출산/육아휴직 대체 포지션으로 17개월(TBD) 근무 예정입니다. 단, 근무기간은 입사일에 따라 +,- 수개월 차이날 수 있습니다.
Responsibilities
- For assigned products and under supervision of Country Lead/Director/Associate Director ensures timely preparation, submission and appropriate follow-up of Marketing Authorization applications to the local health authorities.
- For assigned products and under supervision of Country Lead/Director/Associate Director ensures maintenance of assigned, authorized products through timely submission of variations, renewal and RMP, pre-approval and post-approval HA GMP audit and supplemental marketing authorizations.
- For assigned products ensures high quality labelling translation and artwork management.
- Supports the agency interactions to ensure a seamless submission, assessment, and smooth approval.
- For assigned products and tasks, stays updated on relevant local regulations and guidelines.
- Monitor, review and assess local regulations and relevant information (regulatory intelligence)and inform the relevant stakeholders
- Maintains a positive relationship with internal and external regulatory contacts.
- A senior position entails more advanced and independent responsibilities and acts as a supervisor for selected regulatory activities.
- Mentor junior RA team members and contribute to internal training on MFDS regulations and procedures.
New MA applications for assigned products:
- Under supervision, performs timely and accurate submissions and approvals of assigned new Marketing Authorization applications, in close cooperation with local and global stakeholders, as well as with local HA when applicable. Tracks the process of product registration and product launch process.
Maintenance of licenses for assigned products:
- Under supervision, ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations, renewals and RMPs within the agreed timeframes and communicate approvals to stakeholders in compliance with corporate standard and local regulations.
Compliance:
- For assigned products, ensures timely preparation and maintenance of local labeling, packaging material and other applicable regulatory documents according to company and local standards and relevant Artwork Management procedures.
- Ensures that all internal stakeholders receive relevant information with regard to the regulatory status of the assigned products.
- Ensures the correct and proper utilization of Artwork Management System to generate mock-up and commercial artwork and to implement revisions to artwork.
- Ensures efficient and consistent implementation and use of internal and external regulatory databases (e.g의약품안전나라) and systems (e.g internal RA systems) in the country.
- Ensures that files and archives related to Regulatory are kept updated and complete.
- Participates in establishing and maintaining of relevant Standard Operating Procedures every 3 years or when as necessary to secure that the current regulations are complied with.
- Implementation of updated regulatory documentations (including but not limited to CMC, S&E documents) according to Agency requirements and internal guidance.
- Evaluate the local impact of safety information based on global regulatory authorities(UPSI)or approved product information and report to the local HA as necessary
Editing and labelling:
- In connection with the submission of MA applications and post-approval submissions, provide translation and QRD checks, and ensure quality assurance, including linguistic checks of these documents.
Artwork:
- Prepares artwork, including package leaflets and all other components in a timely and correct manner and according to the relevant Artwork Management procedures.
- Responsible for proofreading packaging components and maintaining an up-to-date file on packaging components.
Cross-functional activities:
- Secures timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention of the Management Team.
- Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice.
- Adequately supports other functions to enable compliance in areas related to regulatory.
Regulatory policy & environment:
- Continuously stay informed about local and international laws and regulations that impact the work.
- Collaborates with local agencies and industry stakeholders to shape the regulatory environment and aligns industry positions with company interests.
- Participates in KRPIA/HA workgroups on selected issues.
Required Education, Experience and Skills
- At least 5-7 years experiences in Regulatory Affairs
- Proficiency in English(Verbal & Written)
- Regulatory Knowledge
- Cross-functional Collaboration
- Regulatory Strategy & Problem Solving
- Strong Communication & Presentation Skills
- Attention to Detail & Quality Focus
- Continuous Learning & Adaptability
Secondary Job Description
Note: There will be an outbound CV screening interview call from our Talent Attraction Business Partner, and the call may come from an overseas number.
Please make sure to answer the international call to proceed with your application.
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
