Malaysia landscape
Job Post
CMS Biotech Pte Ltd

Regulatory Affairs Associate

CMS Biotech Pte Ltd Posted: 4 Month Work From Home
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Description:

Job Responsibilities

 

·       Reports to Head of Regional RA Office

·       Contribute to development of regulatory strategies for new products and changes to existing products in line with business objectives

·       Review, compile and submit NDAs based on local regulations including ICH and ACTD formats for existing product portfolio covering drug and medical device products

·       Manage compilation and submission of responses to queries raised during the evaluation process of NDAs through coordination with international functions like CMC, International RA, Legal, BD, Site responsibility and response publishing teams up to final approval

·       Liaise on regulatory activities required for new product launches based on commercial needs including redressing activities and promotional material reviews to ensure alignment with brand guidelines and registered details of the products

·       Manage compliance of product labels and liaise with supply chain for the implementation in commercial shipments in South East Asia

·       Life cycle management of existing product portfolio to ensure regulatory compliance and licence renewals to support business needs

·       Maintenance of regulatory systems and databases and conducting training to regulatory colleagues in the region

·       Provision of regulatory advice to regulatory colleagues in the region and other colleagues in the organization

·       Collation of information from the region for periodic safety updates reports

·       Stay up to date on regulatory changes in the region

·       Responsible for all regulatory operations that involve liaising work within the company functions such as Production, R&D and QA departments as well as external agencies such as health authorities in Singapore and Malaysia.

·       Product submissions, registration and compliance to international regulatory standards by preparation and submission of technical dossiers (ICH) or technical files to regulatory authorities in South East Asia

·       Manage company regulatory affairs activities including reports, license transfers and renewals to ensure compliance with government requirements and company standards

·       Liaise with international functions like Research and Development and Quality Assurance to ensure timely submission and approval of manufacturing site changes/transfer applications

·       Develop and maintain good and professional relationship with the regulatory authorities and trade associations, to ensure smooth and efficient registration process and influence for positive change of regulatory environment

·       Support registrations in new or overseas export markets for commercial development

·       Engage export parties to establish list of products for export and regulatory management

·       Handle queries from potential export parties as well as overseas health authorities

·       Support compilation of dossiers for submission in export markets based on local regulations

 

 

 

 

 

Qualifications

 

·       Pharmacy, Science degree or equivalent

·       2-5 years relevant working experience in RA settings focusing on SEA or Asia regional product registrations and life cycle management

·       Pharma experience

·       Medical device experience a plus

·       Quality experience a plus


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