Regulatory Affairs Manager

RESPONSIBILITIES:

• Set up regulatory strategy, product registration timeline and ensure well implement.
• Prepare and validate registration dossier for CTA, NDA, Renewal and variation to ensure timely approval and fully meet Chinese regulations and guildlines.
• Responsible for CTA applications, line extension, license renewal, variation applications (such as CMC changes, safety updates, local repackaging, specification upgrades etc.), including establish the filing strategy, source documents collection and application dossiers preparation, filing and following communications, follow the regulatory progress.
• 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.
• 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 (CFDA, CDE, 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.
• Train and develop subordinates, provide good supports, well coordinate with colleagues, and create positive working environment to promote the best performance of team work.
• Establish internal SOP and WI.
• Assist supervisor to complete urgent assignments as required in a timely manner.

MORE SPECIFIC INTRODUCTION

• Therapeutic areas: Gastroenterology, Cardiovascular
• Product type is mostly small molecule (chemical drug, both innovative and generic ones)
• The work includes both CTA, NDA, new product development assessment and life cycle maintenance.

EXPERIENCE:

• 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 CFDA regulations and guidelines;
• Good working relationship with regulatory authorities;                     
• Good command of oral and written English;                              

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