Regulatory Affairs Specialist (Pharma/ Medical Device, Chem) #HDC

Recruit Express Pte Ltd.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist with a strong background in the pharmaceutical and medical device sectors. This role involves monitoring regulatory trends, providing support for product compliance, and engaging with regulatory agencies to ensure adherence to global standards. The ideal candidate will have a degree in a science-related field and experience in regulatory affairs, particularly in product registrations and pharmacovigilance. Join a dynamic team where your expertise will directly impact product safety and compliance in a fast-paced environment.

Qualifications

• Minimum Degree in any science related field.
• 2-3 years of experience in regulatory affairs is preferred.

Responsibilities

• Monitor regulatory trends and integrate new requirements.
• Provide regulatory support for product changes and submissions.
• Assist in negotiations with regulatory agencies.

Skills

Regulatory Affairs

Pharmacovigilance

Statistical Support

Compliance Assessment

Product Registration

Education

Degree in Science

Job description

Regulatory Affairs Specialist (Pharma/ Medical Device, Chem) #HDC

Singapore | Posted: Dec 27, 2024

Responsibilities

1. Monitor emerging regulatory trends and integrate new requirements into department procedures and toolkits.
2. Provide regulatory support to currently marketed products, as necessary.
3. Assess product and manufacturing changes for compliance with applicable regulations and prepare submissions and reports as required by classification and geography.
4. Provide regulatory support to product manufacturing transfers.
5. Provide regulatory support for product design, manufacturing, packaging, sterilization, and labeling changes.
6. Provide statistical support and bridging between Clinical and Data Management/Biostatistics team members.
7. Implement regulatory aspects of Field Actions.
8. Provide regulatory affairs input for product development and manufacturing, including review of specifications, protocols and reports, engineering change notices, nonconforming materials, product complaints, and product failure analysis.
9. Provide regulatory input to the company for compliance with Global, Regional, and HSA Quality System Regulation requirements.
10. Provide input for clinical studies to assure compliance with domestic and international regulatory requirements (GCP), as well as to ensure efficient and approvable study designs.
11. Assist in negotiations with the HSA or other regulatory agencies for assigned projects.
12. Obtain and distribute updated information regarding worldwide laws, guidelines, and standards.
13. Serve as internal consultant on regulatory issues such as recalls, advertising and promotional activities.
14. Develop and deliver presentations to worldwide regulatory agencies. Topics may include submission strategies, technical and statistical approaches, compliance issues or new initiatives.
15. Assist in developing and maintaining positive relationships with device reviewers through oral and written communications.
16. Other tasks, as assigned.

EDUCATION AND EXPERIENCE

1. Min Degree in any science related field
2. Minimum 2 - 3 years of experience in either domestic and regional regulatory affairs would have an advantage
3. Familiar with regulatory affairs such as NDA, variation and renewal of product registrations in Pharmaceutical industry (manufacturer or distributor) would be at an advantage
4. Pharmacovigilance (or safety monitoring/reporting) experiences preferred but not mandatory

Recruiter's Ref Code: #HDC
EA License: 99C4599
Recruit Express Pte Ltd