Regional Regulatory Affairs Executive

Company Description

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.

In Asia Pacific, Santen has a strong presence with direct operations established in several countries. Santen also works with distributor partners, in countries such as Indonesia, Myanmar, Cambodia, Pakistan, Sri Lanka and Australia.

The Regional RA role is key to delivering regulatory success for Santen Asia in key NDAs and LCMs. Leveraging on your in-depth knowledge of current ASEAN / Asia regulations, as well as your networking and lobbying skills, you will have the opportunity to not only liaise with internal cross functional members (local/global) but also external partners in EMEA, US and so on, to ensure the requirements of Asia are met and delivered as planned. You will be part of a growing and dynamic global pharmaceutical development team of a leading company delivering excellence in ophthalmic therapeutic area.

**Job Description**:
**_
Product License Registration, Maintenance and Lifecycle Management _**
- Work closely with Regulatory Affairs and Regional Marketing team to facilitate and track the registration of new products, renewals and license variations in Asian countries according to business strategy.
- Interface with relevant regional cross functional members to ensure regulatory strategies and processes are aligned to business priorities, keeping them informed of any regulatory changes or approvals when necessary.

**_ Regulatory Affairs Relationship and Project Management_**
- Work with Ltd Regulatory Affairs RA team to improve the quality of product dossier according to regulatory requirements, in order to shorten the cycle time before & after product submission.
- Lead as RA PIC for assigned products, working under supervision of Regional RA Manager.
- Collaborate with regional cross functional members (including Marketing, Legal and Medical Affairs teams) to review and approve regional promotional materials to ensure compliance with internal polices & external regulations.
- Provide advice on clinical trial regulatory requirements of the region based on request from HQ Clinical team.
- Coordinate regulatory requirement surveys with local RA, collate and communicate results to relevant stakeholders.
- Monitor regulatory environment and competitor regulatory activities, keeping relevant regional and HQ functions updated on key changes where appropriate.
- Network with industry players to learn from industry's best practice for sharing with Regulatory Affairs, to continuously improve internal processes.
- Consolidate monthly reports from Asian countries, with review by RA Country Lead, Asia, for reporting to Head of Regulatory Affairs, Asia.

**_ Product Compliance and Process Improvements_**
- Support to make regional regulatory SOPs to achieve compliance with international and corporate regulatory SOPs and other processes in order to maintain good corporate practices and Santen’s reputation.
- Handle the completion and timely submission of monthly regulatory reports.
- Comply to maintain all regulatory documents, making sure that all information is retained in accordance with Santen’s internal documentation policies and processes.
- Support budget planning and forecast review of Asia RA expenses for relevant RA cost centers.

**Qualifications**:

- Strong working knowledge of current regulatory requirements in Asian countries.
- Performance driven with ability to work both independently and as a team player.
- Strong interpersonal skills to work effectively with other functions across the company.
- Good communication & project management skill (for both written & spoken).

Additional Information
**Grow your career at Santen**

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital stat