Regional Regulatory Affairs Manager

5 hours ago

Singapore INTEGRITY PARTNERS PTE. LTD. Full time

**Join a renowned multinational corporation (MNC) recognized for its diverse portfolio of over-the-counter (OTC) consumer health products.**:
With a steadfast commitment to meeting evolving healthcare and wellness needs, they offer an expansive range of premium consumer products. As they expand across Asia, they are seeking a talented and experienced Regional **Regulatory Affairs Manager **to play a pivotal role in our dynamic team.

As a Regional Regulatory Affairs Manager, you will ensure regulatory compliance and manage projects across our consumer health portfolio in the Asia region.

Your primary responsibility will be to coordinate submission documents, address regulatory authority queries, and secure approvals for new products and variations. With your expertise, you will devise effective submission strategies, foster collaboration with key departments, act as the primary internal regulatory contact, and contribute to streamlining regulatory procedures and processes.

**Main Responsibilities**:

- Lead the coordination of submission documents and timely response to regulatory authority inquiries, securing approvals for new products and variations in Asia.
- Develop and execute comprehensive submission strategies for regulatory approvals across Asian markets, ensuring expeditious market access and optimizing regulatory success.
- Foster seamless collaboration and communication with key departments (Regulatory Affairs, Quality, Supply Chain, Marketing, Business Development) to provide regulatory insights and drive regional initiatives.
- Act as the primary internal regulatory contact, providing coordination and support to in-country regulatory teams and distributors throughout Asia.
- Support the establishment and implementation of standardized regulatory procedures and processes, enhancing operational efficiency across the region.
- Ensure seamless integration of the regulatory information management system with other organizational systems.
- Provide regulatory support for due diligence activities related to innovation, business development, and commercial expansion projects.
- Monitor and analyze new regulatory legislation and guidance across Asia, proactively interpreting their impact on the company in collaboration with in-country regulatory teams and stakeholders.
- Support competitive intelligence efforts by gathering and analyzing regulatory information pertinent to competitors.

**Requirements**:

- Possess a minimum of 5 years' experience in regional regulatory affairs within the pharmaceutical products, food, health supplements, herbal medicines, medical devices, or cosmetic products industry.
- Hold a degree in Pharmacy, Life Sciences, or a relevant scientific field.
- Familiarity with the regulatory framework in Asia, including comprehensive knowledge of clinical, regulatory, registration, and compliance principles.
- Exceptional multitasking abilities and strong project management skills.
- Proficient in interpersonal communication, influencing, and engagement, fostering effective collaboration across teams.

To seize this exciting opportunity, interested applicants are requested to submit an up-to-date resume showcasing relevant qualifications and experience.

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

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