Regulatory Affairs, SEAK

Apply now »
Apply now

Date: Nov 22, 2018

Location: Seoul, Seoul, KR

JOB SUMMARY

  • Coordinate and act as a bridge with GRA and UCB partners in assisting in new product registration, product life cycle management and maintenance of database with registration information and artwork management in compliance with company policy in South East Asia region.
  • Manage and lead activities related to registration of new products and maintenance of existing registration with optimal labels, in compliance with company policy/strategy and health authority regulations in Korea.

 

MAJOR ACCOUNTABILITIES

Region RA

 

  1. Coordination, tracking and archiving submission related data

    a. Support to maintain, track and archive registration information with regards to new product registration, and life cycle managements for partners in SEA and GRA.

           b. Operate and comply with global submission system for SEA.

      2. GRA Business Tool Lead and labelling coordination

           a. Liaise with business partners and cross-functional leaders for effective communication on daily operational RA related issues.

           b. Coordinates creation/ revision of labelling according to the UCB global policies and procedure and tracking of local label-CCDS compliance and

           recording reasons for differences.

           c. Coordinate with GRA on RA impact assessment in variations assessment based on information provided by partners.

           d. Coordinate with GRA or functional leaders with advice regarding regulatory matters.

           e. Main point of contact for area for global artwork request form (GARF) process and assist all SEA country partners in completion of GARF artwork

           management process and utilize GMPS.

      3. Liaise with GRA/UCB consultants to provide stake holders with the regulatory intelligence and the regulatory insight as and when necessary.

 

 

Korea RA

 

  1. Provide the regulatory impact assessment for labeling, CMC or any changes.
  2. Plan the registration submission/approval based on the regulatory impact assessment.
  3. Provide internal/external stakeholders with the registration intelligence in a timely manner.
  4. Provide appropriate regulatory insight in various company projects and collaborate with other departments to be able to maximize values.
  5. Create/revise/maintain local labeling in accordance with global/local procedure and local regulations.
  6. Create/revise the product artworks in accordance with global/local requirements and ensure to implement the latest labels on artworks.
  7. Maintain and archive registration information in line with company policy.
  8. Reviews promotional and educational material in line with regulatory requirements applicable in Korea.

 

EDUCATION & QUALIFICATION

  • 2-5 y experience in the regulatory affairs
  • Experience with Korea NDA and/or biological applications, knowledge and understanding of drug development processes.
  • Experience with local or regional regulatory affairs and processes & good network of influence in relevant regulatory authorities.

Specific skills/competences

  • Strategic & analytical thinking
  • Effective interpersonal and communication skills
  • Knowledge and expertise in drug development/knowledge, Interpretation and use of
  • regulations, policies and procedures
  • Ability to interpret and apply the rules and regulations for the company's business success
  • Influencing and networking
  • Planning and project management
  • Strong communication skills (written & spoken) in English language (apart from local

    language)


Job Segment: Regulatory Affairs, Law, Compliance, Database, Project Manager, Legal, Technology

Apply now »
Apply now
Find similar jobs: