Regulatory Affairs Specialist

6 days ago

Singapore Johnson & Johnson Full time

***

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) 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**:
**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.
- 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

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