Manager, Regulatory Affairs

Job description

Position Overview

Independently manage projects of pipeline products and registered products, include but not limit to CTA, NDA, Renewal, Variations and related regulatory agency interactions. Achieve regulatory milestones within company determined timeline.

• Communicate with global RA and other stakeholders Preparing registration dossiers and responses to questions from CDE and other related agencies
• Follow up registration procedure
• Make good relationship with officials/reviewers
• Organize the preparation for CDE interactions (Pre-IND and Pre-NDA, etc.), include written consultation and panel meeting Get final registration permits Get related registration regulations knowledge and utilize in daily works
• Support manager to provide RA input on the strategic planning for all responsible products Requirements At least
• 8 years working experience in pharma Industry Over 6 years’ experience in RA field.

Experience with ophthalmology products is preferred Bachelor and above in medicine, pharmacy or related disciplines Good computer skill in EXCEL, POWERPOINT and WORD Good interpersonal communication skill Good English skills both in spoken and written Additional location(s)

Compensation Information

Required Skills: Detail-Oriented, Global Communications, Pharmaceutical Regulatory Affairs, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE 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

Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 12/31/2026 *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.