Regulatory Affairs Manager
7 days ago
To provide regulatory affairs support and consultancy to internal and external stakeholders in a business‐oriented way.
Liaise with a range of colleagues from marketing team, R&D, supply, and global/regional regulatory teams.
Work closely with government agencies, external partners and contractors to ensure regulatory, safety and medical affairs issues are properly managed and resolved.
**Responsibilities/Accountabilities**
- Regulatory Affairs ‐ Singapore_
Regulatory Requirement
- Lead and/or co‐ordinate change control involving regulatory matters.
- Maintenance and update of licenses in compliance with local regulatory requirements.
- Develop and maintain a database of local regulatory requirements.
- Monitor and interpret local regulatory issues/trends/updates that will impact the marketability of company products, ensuring that the business unit is fully aware of the impact.
- Proactively leading the development and implementation of strategies to ensure regulatory compliance that results in competitive advantage for the company.
Regulatory and Safety Advice
- Provide regulatory expertise in area of advertising, label claims, printer materials and importation requirement.
- Work with R&D and Marketing team to develop and protect key brands’ product claims.
- Pharmacovigilance/Drug Safety Officer (Deputy)_
- Assist Drug Safety Officer (Singapore) in collection and reporting of all adverse events received in Singapore.
- Monitor regulatory guidelines and intelligence reports for changes in regulations governing safety reporting, class labelling for relevant products.
- Coordinate measures to address potential and identified safety risks.
- Fulfill reporting requirements and timeline to local authority, when required.
- Ensure that all inquiry by authorities can be addressed completely and in due time.
**Requirements**:
- Good knowledge of current local regulatory requirements for IFCN (preferred), cosmetics and medical devices.
- At least 2 years of regulatory affairs experience in Food and Beverage industry.
- Degree in Science, Food Science or related studies.
**Description**:
- Want to steer the growth of a major global brand? As a Regulatory Affairs Manager you’ll have the freedom to show us what’s possible and help drive innovation that makes an impact. Globally.**Regulatory Affairs Manager**
**Central Singapore, Singapore**
**Competitive Salary & excellent benefits package**
- Responsible for a major brand or category, you’ll play a critical role driving innovation and developing new products. You’ll navigate a complex regulatory environment. As a steward for our brands, you’ll ensure our product portfolio supports our ambitious growth plans. You’ll anticipate and influence regulatory changes and lead our thinking about what’s possible. You’ll develop global registration dossiers and technical documentation to ensure our products are safe, efficient and continue to make our customers lives better.**You’ll succeed because**
- you’ve a scientific background and an understanding of Regulatory Affairs. You know new product development, registration and submission processes. You’ve close attention to detail in preparing technical dossiers, variations and renewals. You’re an excellent communicator, influencing others to make fact-based decisions. You’re results-orientated, are willing to take the lead in challenging situations and are always looking to make things better. Like us.**You’ll love it because**
- you’ll get to make an impact like never before. You’ll be responsible for your own projects - we can’t wait to hear your ideas. The products you help us get out there will make people’s lives better. Our iconic brands will provide an incredible platform for you. And our dynamic, ownership-driven culture will help bring the very best out of you, every day.**Equality**:
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.
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