Job Description

POSITION SUMMARY

The Regulatory Affairs Specialist has the responsibility to 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.

Adheres to environmental policy, procedures, and supports department environmental objectives.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES

Main areas of responsibility:

• Responsible for South East Asia (SEA) markets with supervisory responsibility.
• Supports regulatory department to ensure efficient and compliant business processes and environment. Responsible for all regulatory related matters not limit to registration of new products/changes/renewal licenses, Advertisement and promotional materials review, labelling etc in SEA.

1) Determine and communicate submission and approval requirements.
2) 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.
3) 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.
3) Monitor and assess impact of changing regulations on submission strategies.
4) Compile, prepare, review and submit regulatory submission to authorities.
5) 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.
6) Provide support to requests from post-market clinical studies

QUALIFICATIONS

Minimum education required for competent performance: Bachelor of Science Degree with 2-3 years of experience

Minimum experience:

• Strong communication, organizational, negotiation and interpersonal skills.
• Expert knowledge, understanding and application of principles concepts and practices of government regulations.
• Ability to organize and analyze technical data and identify issues or gaps.
• Foundational regulatory knowledge to maintain legal status of products and minimize risk.
• Broad based technical knowledge and skills in diverse areas of business (e.g., R&D, Operations, QA, Laboratories, Marketing, etc.) and ability to effectively negotiate and influence affiliates and Regulatory agencies are a plus. Self- motivated and committed to a team approach

About Johnson & Johnson

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

At Johnson & Johnson, we\'re on a mission to change the trajectory of health for humanity. That starts by creating the world\'s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

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