Regulatory Affairs Manager, Contrast Media  

[Your tasks & Responsibilities]

Korea Specific Tasks

• Work closely with regional and global regulatory affairs in setting and leading local regulatory strategic and operational matters of assigned portfolio to fulfil the local business strategies, in coordination with local functions.
  
  
• Ensures transparent, timely and efficient communication with business, supply chain and other local functions and global regulatory affairs, providing regulatory expertise to achieve common decisions. Effectively manages priorities within responsible portfolio.
  
  
• Functional excellence responsibilities:
  

1. Leading contribution to operational activities within the team to assure diligent and professional regulatory checks and timely delivery of documentation, compliance support to R&D and other stakeholders on development activities and issue management.
   
   
2. Continuously identifies and implements efficiency, productivity goals for integrated RA organization (resources, processes, systems).
   
   
3. Works closely with regional and global regulatory to identify resource requirements within assigned geography and manages own resources to meet regulatory needs. Ensures early identification of conflicts between projects and ensures transparent and aligned prioritization in consultation with global regulatory and Head of Commercial Radiology. 
   
   
4. Ensures preparation of the application files for products based in the documentation from RA regulatory partners in accordance with local regulation, is of acceptable standard and quality for the respective authorities. 
   
   
5. Where applicable, ensures the preparation of the application files for clinical trials, based on the documentation provided from RA regulatory partners, are in accordance with the local regulations and presents them to the respective authorities, where locally relevant. 
   
   
6. Work closely with Pharmacovigilance (PV) for PSUR and AE reporting as needed.
   
   
7. Work closely with Quality to provide regulatory expert input to manage product complaints and recall process, including health authority interaction and communications. Provide necessary functional input and documents to enable Quality to complete local compliance checks and develop local QSD process.
   

APAC Specific Tasks

• Ensures regulatory priorities and project requirements/status between global regulatory contrast media staff and internal regional country colleagues, including decisions with the SKU gatekeeping process.
  
  
• Ensures that regional/local CME regulatory requirements are identified, confirmed, and updated as needed through input from local affiliates. Communicates requirements on an ongoing basis to global regulatory affairs to ensure compliance with applicable regulations.
  
  
• Works in partnership with global Regulatory Affairs and local country affiliates to ensure the creation and approval of regulatory submissions.
  
  
• Contact for regional APAC / local KR management on Regulatory Affairs Contrast Media matters (such as developmental projects, life cycle projects and maintenance), GRT membership, and to bridge between global and local Regulatory Affairs and commercial teams, as necessary to ensure business needs are met.

[Qualifications / Requirement]

• Master’s degree in Life Sciences or equivalence scientific degree with minimum of 5-7 years pharmaceutical industry experience in regulatory affairs with at least 2 years of proven leadership/technical specialist role experience in health authority interactions and negotiations, in managing projects and resources and demonstrated track record of providing workable solutions to complex regulatory problems. Sound pharmaceutical product knowledge and hands-on experience across various types of applications, experience with contrast media an asset.
  
  
• The experience to act as an effective business partner to country commercial organization. He/She will need to be a self-starter with excellent interpersonal and communication skills to facilitate the ability to negotiate and influence others, while dealing with issues which have considerable scientific and regulatory uncertainty.
  
  
• Analytical capability to evaluate complex/ambiguous situations and to proactively identify potential issues and future trends and to translate into business cases. Ability to come up with solutions to deal with heterogenous environment.
  
  
• Fluent in English and local language. Excellent communication skills to communicate effectively both orally and in writing, with proven persuasive, assertive and negotiating skills to represent the company at external meetings and report issues, strategies and activities to KR country management and regional management teams as well as RA global/regional management.
  
  
• Ability to focus on multiple issues at one time, ability to organize, prioritize and direct diverse activities in a changing environment often under time pressure.
  
  
• Excellent interpersonal skills to both independently and with local/global counterparts in line with our company LIFE values and to effectively support KR and APAC businesses and RA goals.