Johnson & Johnson
Regulatory Affairs Specialist
Regulatory Affairs Specialist
1 year contract with high potential to renew/ convert
Come and join us!
Do you wish to work in a world-class organization trying your hands at something you have dreamt of doing?
“FIND YOUR PLACE” by joining our client Johnson & Johnson
Get an opportunity to explore new technology, learn new skills, enjoy the diverse and open culture, engagement and care, flexible working model, career opportunities, competitive salary and bonus, and endless amenities and benefits.
Johnson & Johnson WORKSENSETM (via Randstad Sourceright) is responsible for finding, engaging, and contracting talent for the Johnson & Johnson contingent workforce.
About Johnson & Johnson
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science - bringing innovative ideas, products, and services to advance the health and well-being of people.
As an equal opportunity employer Johnson & Johnson value diversity at their company. They don’t discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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
- University degree in any Science studies
- 1-5 years work experience in the in Regulatory Affairs for SEA countries
- Proficient in Microsoft Office
Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.
Interested parties, please apply through this link https://jnj-apac.talent-pool.com/projects OR click on APPLY button.
Alternatively, you can share your CV at firstname.lastname@example.org
EA License: 94C3609
Reg No: R1440247