Sr. Spclst, Regulatory Affairs
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Key skills for this role
About the Role
Responsible for supporting the registration, maintenance, labeling, and compliance of assigned products in line with local and regional regulatory requirements.
Key Skills for This Role
Full Job Posting
Job Description
Responsible for supporting the registration, maintenance, labeling, and compliance of assigned products in line with local and regional regulatory requirements.
Builds strong relationships with health authorities and internal stakeholders to ensure timely approvals, continued compliance, and effective regulatory support for business needs.
Key Responsibilities
- Prepare, submit, and follow up on new Marketing Authorization applications with local authorities.
- Maintain product licenses through variations, renewals, and supplemental applications.
- Ensure timely, accurate, and compliant labeling translations and artwork preparation.
- Support Clinical Trial Applications and agency interactions in cooperation with internal stakeholders.
- Performs timely and correct submission and approval of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, customer service, marketing and external affairs departments,
- Monitor regulatory updates, guidelines, and pipeline developments; assess business impact and support action planning.
- Collect and share relevant regulatory intelligence.
- Support business initiatives through collaboration with local, regional, and global teams.
- Maintain effective relationships with internal teams and external regulatory authorities.
- Support compliance activities, including product information, artwork, databases, and regulatory archives.
- Contribute to SOPs, regulatory documentation, and implementation of updated requirements.
- Provide regulatory input to cross-functional projects, launches, pricing and reimbursement activities, and quality-related matters.
- If applicable, manage and develop direct reports, including coaching, training, and workload prioritization.
Qualifications & Experience
- Master’s degree in pharmacy, life sciences, or a related field.
- Minimum 4 years’ experience in regulatory registration
- Experience dealing directly with regulatory authorities.
- Strong knowledge of local and EU pharmaceutical regulations and procedures.
- Excellent communication, organization, and planning skills.
- Strong attention to detail and ability to manage multiple priorities.
- Ability to work collaboratively and influence internal and external stakeholders.
- Proficiency in local language and English, plus standard PC applications.
Required Skills
Adaptability, Adaptability, Audits Compliance, Business, Business Initiatives, Clinical Trials, Detail-Oriented, Divestitures, Drug Regulatory Affairs, Employee Training Programs, Environmental Regulations, Global Communications, Internal Customers, Management Process, People Management, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Product Approvals, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Documents, Regulatory Issues, Regulatory Operations {+ 2 more}**Preferred Skills:**
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.
Job Posting End Date
05/25/2026* **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.**
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