Regulatory Affairs Manager

• Over 5 years working experience in regulatory affairs for pharmaceuticals including more than 3 years in the project management post;
• Solid registration project management skills;
• Effective problem solving and planning capabilities;
• Good knowledge of NMPA regulations and guidelines;
• Good working relationship with regulatory authorities;
• Good command of oral and written English;
• Good communication skill.

RESPONSIBILITIES

• Provide regulatory input to supervisor for decision making on registration filing strategies.
• Set up product registration timeline and ensure well implement.
• Prepare and validate registration dossier to ensure fully meet Chinese regulations and guidelines.
• Track on-going projects and handle technical issues from regulatory authorities to achieve registration approvals on schedule.
• Develop and maintain tracking system for registration procedure to ensure clear registration status; timely report to the line manager.
• Develop and implement internal processes and system to support regulatory submissions and approvals in the most efficient.
• Provide regulatory support to Medical and Marketing team as well as other company personnel.
• Review promotion materials according to the internal SOP.
• Communicate with area RA & local functions to keep the effective registrations, and ensure no delay for the market supply due to IDL renewal.
• Establish and maintain good working relationships with regulatory authorities (NMPA, CDE, CFDI, institute for drug control, and so on) to guarantee effective product registrations.
• Follow up policy change related to business in terms of RA and share with cross-functions timely.
• Assist supervisor to complete urgent assignments as required in a timely manner.

MORE SPECIFIC INTRODUCTION

• Therapeutic areas: Women Health, Gastroenterology, Cardiovascular.
• The work includes both life cycle maintenance and new product development
• Product type is mostly small molecule (chemical drug, both innovative and generic ones).
• The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY

Regulatory Operations

DIVISION

EPD Established Pharma

LOCATION

China > Shanghai : 388 W. Nanjing Road, Ciros Plaza

ADDITIONAL LOCATIONS

WORK SHIFT

Standard

TRAVEL

Not specified

MEDICAL SURVEILLANCE

Not Applicable

SIGNIFICANT WORK ACTIVITIES

Not Applicable