Regulatory Affairs Manager (Support China Remotely)

Inviting applications for the role of Manager in Regulatory Affairs pharmaceutical products.

You should have relevant years of experience in regulatory affairs with must knowledge of current regulatory guidelines.

Responsibilities

• In this role, you will be responsible for all local regulatory affairs, lifecycle management (LCM) and maintenance activities for assigned products, including but not limited to the following:
• Regulatory Intelligence for the portfolio in scope
• Interact with colleagues in other global functions and Regulatory Affairs to deliver high quality dossiers, documents, and materials to local Regulatory Affairs in accordance with business priorities
• Follow internal steps for a new SKU (cross functional alignments including Product Supply, etc.)
• Develop up-to-date knowledge to guidelines and regulatory requirements, as well as technical trends
• Support importation of goods (where applicable)
• Support tender (where applicable)
• Review advertising / promotional material against approved label (where applicable)
• CTA (Clinical Trial Applications for Established Products) (where applicable)
• Parallel Import check of goods (where applicable)
• Global regulatory team participation for selected established portfolio products
• Primary contact for Local Health Authority on delegated products
• Leads project delivery teams.
• Ensuring the project team is onboard and aligned to the project expectations
• Ensuring business requirements are defined with precision & quality, driving execution and delivery
• Create a motivating & inspiring environment, foster innovation, ideas, and quality
• Contributes to business development and growth strategy
• Lead/Contribute to implementation of Regulatory Information Management system / platform and associated data processes & data operations
• Communicates & collaborates effectively with diverse groups both on the business & IT side, including senior stakeholders – ability to articulate complex scenarios succinctly and targeted to the group
• Ensure customer success throughout the engagement
  
  

Qualifications we seek in you!

Minimum Qualifications

• Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry.
• Mandatory Knowledge of China regulation and well adheres of Chinese and English language
• Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously
• Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviours to drive high quality deliverables
• Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations, and takes a new perspective using existing solutions
• Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.
• Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures
  
  

Key Attributes

• Enthusiasm & confidence
• Adhere to our principles and values.
• Time Management skills.
  
  

Minimum Qualifications

• Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry.
  
  

Preferred Qualifications

• Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry.