Manager, Regulatory Affairs

Responsibilities

• 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.