Senior RA Specialist, Thailand (JO-160919-110210 )
RGF HR Agent Singapore Pte Ltd
jobsDB ref: JSG400003002959414
EA License No. 10C2978
- Leading Biopharma company
- Leading the Regulatory function
Our client is a global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. The company's products are available in more than 100 countries, across core therapeutic areas.
- Compile and submit registration dossiers to local authority to obtain regulatory approvals in a timely manner.
- Maintain product licenses by ensuring that all renewals, variations, label updates are submitted and approved within the required time-frame to ensure supply continuity and regulatory compliance.
- Monitor regulatory environment and take proactive actions to notify company of new requirements that may impact submission strategies.
- Maintain proper record of regulatory submissions and approvals and update databases for RA information /documents.
- Review local promotional materials.
- Represent Regulatory Affairs in project teams to provide relevant regulatory advice.
- Close and effective follow up with local regulatory authorities on company’s submissions.
- Close and effective collaboration with cross functional teams at local and region level.
- Provide support for tender submission.
- Bachelor degree or above in related scientific discipline
- Minimum 5 years of relevant experience in pharmaceutical industry
- Strong knowledge of RA requirements
- Ability to work independently with attention to details
- Ability to multi-task and work well under pressure
- Strong oral communication and relationship building skills
EA License No.: 10C2978
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About RGF HR Agent Singapore Pte Ltd
RGF is the global brand of Recruit Holdings, the world’s fourth largest recruiting and information service company and the largest in Japan, generating over US$14 billion in net annual sales. For more than 56 years, RGF provides comprehensive HR solution and talent acquisition services which include retained and contingency executive recruitment and market mapping, senior to staff level specialist and contract recruitment as well as payroll services. RGF operates in more than 45 offices across 26 cities in 11 countries and markets in Asia with in-country specialist consultants.
EA License No.: 10C2978