Regulatory Affairs Manager, Singapore

2 weeks ago

Queenstown, Singapore Alcon Full time

The Regulatory Affairs Manager is responsible for managing regulatory approval across the organization and outreach programs. Engages in trust-based scientific discussion with regulatory officials, while efficiently gaining regulatory go-ahead for top priority products and programs.
- Direct the preparation and presentation of all necessary regulatory documentation across the organization, through active outreach to regional and global management of the RA team
- Ensure submission for product registrations are carried out in a timely manner in compliance with internal and external regulatory requirements.
- Responsible for department supervisory, issues management, establishing and maintaining regulatory networking internally and externally and preparing the company on planned/upcoming regulations to ensure business objectives are met.
- Develop regulatory-outreach plans working closely with other stakeholders (e.g., Regional/Global RA, Medical, Quality, Franchise, Research & Development) to ensure efficient approval of in-country products and programs
- Allocate RA personnel and resources to provide necessary documentation and support for high-priority compounds and products
- Provide necessary regulatory information, updates and documentation to organization, regional and corporate personnel, as necessary
- Ensure clear communication channels between stakeholders (e.g., Regional/Global RA, Medical, Quality, Franchise, Research & Development)
- Establishes and maintains reasonable and responsible regulatory climates locally though networking.
- Develops, retains, and improves technical knowledge and skills of local RA associates.
- Continuously acquires updated technical knowledge through training.
- Assume role of responsible person in Therapeutic Product Importer’s and Wholesaler’s licence.
- Other duties as and when assigned

Education
- Degree in Engineering or Science or related scientific discipline, or equivalent

**Experience**:

- Minimum 7 years' experience in management of regulatory approval processes
- Clear and full understanding of relevant pharmaceutical and medical device regulation and approval processes
- Ability to engage regulators in trust-based scientific discourse
- Excellent oral and written communication skills
- Strong presentation skills
- Ability to lead and develop other scientific and professional reports
- Pharmacist License preferred

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