Title: Regulatory Affairs Manager
Location: Suseo (Gangnam-gu), Seoul, Korea
Summary
The Regulatory Affairs Manager is responsible for preparing accurate, clear and concise regulatory documents for the Cell Therapy and Gene Therapy (CGT) Raw Materials and excipients and the regulated products, especially In-Vitro Diagnostic and Medical Device (IVD / MD), within Biosciences Division (BID) for South Korea market. The incumbent will also be responsible for providing knowledgeable input to interdisciplinary project teams and management, and to work closely with the business and commercial teams to provide regulatory strategy in CGT Raw Materials and excipients and regulated products.
The incumbent will assess current/emerging regulations, guidance documents and corporate/industry standards for impact on the business area, collaborate effectively with cross functional partners across project teams, third party suppliers and/or development partners to ensure effective project communication and coordination for submission assignments and special projects. The role will call for a strong strategic orientation, an understanding how the regulatory affairs function both drives commercial outcomes and ensures compliance with operating codes and ethical principles.
Responsibilities
- Provide cross functional teams with regulatory requirements for regulatory submissions, including CGT and IVD/MD
- Review new and existing Korean regulations and guidance’s and prepare impact analysis as needed for projects/business in South Korea
- Prepare and submit regulatory submissions to Korean authorities and lead clinical studies where needed in support of the CGT and IVD/MD product filings
- Ensure regulatory project deadlines and required performance standards are established and met
- Provide guidance and support for regulatory requirements related to CGT materials and excipients in South Korea, including identifying National Standards & guidance, coordinating technical specification for product submission, strategically supporting clinical studies, to mitigate risks for regulatory and compliance activities in South Korea
- Support CGT products’ market access in South Korea to meet business requests
- Lead Post Market Surveillance of BID regulated products in South Korea.
- Work with cross functional teams, operations and customers to resolve and implement corrective and preventive actions resulting from technical complaints
- Participate in company regulatory/quality audits and assist, as needed
- Working within Global/APAC Regulatory Affairs organization, provide regulatory and scientific advice to other areas
- Participate in appropriate exhibitions and conferences
- Develop contacts with consultants and regulatory agencies
- Other tasks assigned by line manager
Education and qualification
- Bachelor’s degree or higher degree in life science, biological science and pharmacy
- Over 7 years of relevant experience in regulatory affairs related to Pharmaceutical, Medical Device and/or In Vitro Diagnostic Device
Essential Skills and Abilities
- Regulations, standards and guidelines related to medical devices / in vitro diagnostic / pharmaceuticals in Korea, applying both strategic skills and execution
- Acute about the regulation change, skillful in the regulatory and strategy analysis.
- Strong planning and organizing registration management skills
- Skillful in communication, effective written, verbal and presentation skills in the area of regulatory affair applications
- Excellent analytical skills, results-oriented and a creative problem solver
- Ability to work effectively and collaboratively, across cultures and functions
- Able to work under pressure and flexible working hours based on business requirements