Regulatory Affairs Manager

6 days ago

Singapore INTEGRITY PARTNERS PTE. LTD. Full time

**OVERVIEW**:
Currently representing an MNC with well-known brands of over-the-counter (OTC) consumer health products and with a clear vision to provide an extensive range of premium consumer products that meets the evolving healthcare and wellness needs.
- Portfolio - Consumer Health, Regional (Asia)
- Product Range includes Pharmaceutical, Medical Devices, Cosmetics, Herbal Supplements

**MAIN RESPONSIBILITIES**:

- Manage regulatory projects by coordinating the preparation of submission documents, responding to regulatory authority questions, and obtaining approvals for new products and variations across Asia.
- Develop and implement submission strategies for regulatory approvals across Asia, ensuring timely market access and maximizing the likelihood of regulatory success.
- Facilitate collaboration and communication with key departments (such as Regulatory Affairs, Quality, Supply Chain, Marketing, Business Development) to provide regulatory input and drive regional or cross-departmental initiatives.
- Act as the primary internal regulatory contact for in-country regulatory teams and distributors in Asia, ensuring effective coordination and support.
- Support the establishment and implementation of regulatory procedures and processes to enhance operational efficiency and standardization across Asia.
- Ensure alignment of the regulatory information management system with other organizational systems.
- Assist in regulatory due diligence for innovation, business development, and commercial expansion projects by providing regulatory support.
- Monitor and report on new regulatory legislation and guidance across Asia and collaborate with in-country regulatory teams and other stakeholders to interpret and anticipate the impact on the company.
- Support competitive intelligence efforts by gathering and analyzing regulatory information related to competitors.

**Requirements**:

- At least 5 years' experience in regional regulatory affairs (pharmaceutical products, food, health supplements, herbal medicines, medical devices and/ or cosmetic products)
- Pharmacy, medical or relevant science degree
- Familiar with regulatory framework in Asia, including fundamental principles of clinical, regulatory, registration and compliance issues
- Great multi-tasking ability and project management skills
- Strong interpersonal, communication, influencing and engagement skills.

**Interested Applicants**:
To apply, kindly submit your up-to-date resume, highlighting your pertinent qualifications and experience.

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502

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