Associate Specialist, Regulatory Affairs

Job Description
Associate Specialist, Regulatory Affairs
New MA applications for assigned products
• Under supervision, performs timely and correct submissions and approvals of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, customer service, marketing, external affairs departments, outcomes research on sub-regional, regional and global level, as well as with local regulatory authorities as appropriate, depending on procedure type. Tracks process on products registration and major new indications.
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, with a high standard and within the agreed timeframes and communicate approvals to stakeholders through the correct processes.
Compliance
• Builds and maintains standard Regulatory Official Files as well as Marketing Authorization filing and approval binders according to local SOPs.
• Ensures that regulatory databases and systems are kept updated and complete.
• Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
• Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
• Adequately support other functions as applicable to enable compliance in areas related to regulatory.
Editing and labelling
• In connection with submission of MA applications and post-approval submissions assists in preparation, translation and QRD check and performs quality assurance including linguistic check of these documents.
Artwork development
• Ensures that artwork including all package components (leaflets, labels, outer cartons etc), is developed in a timely and correct manner and according to relevant Artwork Management procedures.
• The incumbent proofreads packaging components and is responsible for maintaining an updated file on packaging components, as applicable.
Additional location(s) Compensation Information:
Required Skills:
Adverse Event Report, Audits Compliance, Data Quality Assurance, Document Control Systems, Electronic Common Technical Document (eCTD), Employee Training Programs, Policy Implementation, Records Retention Management, Regulatory Applications, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Strategy Development
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description:
의약품 허가 및 변경허가 업무 지원
제품 허가 유지관리 (Lifecycle Management)
Regulatory Compliance 및 문서 관리
라벨링 및 Artwork 검토·관리
식약처 및 유관부서와의 협업지원
이 포지션은 1년 계약직입니다.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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.
Employee Status:
Temporary (Fixed Term)
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
11/20/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.