Johnson & Johnson
Regulatory Affairs Specialist
Supports regulatory department to ensure efficient and compliant business processes and environment. Assists in the registration of new products/changes/renewal licenses by preparing documentation needed for registration submissions in Singapore, Malaysia and rest of ASEAN countries
- Determine and communicate submission and approval requirements.
- Participate in new product development teams to provide input and expertise on regulatory requirements, determination of global regulatory strategies, review and approval of documentation to support regulatory submissions worldwide.
- Assess the acceptability of documentation for submission filing to comply with regulatory requirements for clinical trials, marketing applications and corporate goals, to secure submission approval.
- Monitor and assess impact of changing regulations on submission strategies.
- Compile, prepare, review and submit regulatory submission to authorities.
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies and complete all regulatory projects as assigned
- Review and approve advertising and promotional items to ensure regulatory compliance.
- Provide support to requests from post-market clinical studies
Required Key Skills / Qualifications:
- Degree holder with 1-3 years of regulatory field experience in Singapore and ASEAN countries
- Ability to build good relationship with internal and external customers
- Good computer skills
- Strong team spirit, independent, diligent and strong contributor
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EA License: 94C3609
Reg No: R1440247