Regulatory Affairs Manager

2 days ago

Jakarta, Indonesia Galderma Full time

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day. We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.

**Regulatory Affairs**:

- Lead the regulatory strategy and execution efforts, ensuring regulatory advice and input is proactively provided to local business strategies with regards to feasibility, requirements and timelines, taking into account local requirements and local business needs.
- Perform regulatory maintenance of registered products or ingredients (including review of product inserts, submissions of variations and permits) to ensure products remain compliant with all relevant government, industry and corporate requirements throughout their marketed life. To this end, ensure product packaging and associated information are updated, timely implemented and maintained in accordance with the current product licenses, as well as ensure that Marketing Authorizations are updated in line with Company Core Safety Information according to Corporate requirements.
- Ensure local implementation of GRA mandatory SOPs and training
- Review and approve promotional and non-promotional materials ensuring their compliance with local regulations, code of conduct and internal guidelines. Coordinate review with the responsible functions in the country. Ensures consistency and conformity to the various published guidelines
- Review proposed product labels for regulatory assessment and submit to register label changes to the relevant health authority with the aim of attaining the most competitive product labels (whilst maintaining ethical standards) and the earliest possible commercial launch
- Manage in-house regulatory files, documentation and databases (RIMs) ensuring that all files are up-to-date and compliant
- Keep abreast of relevant regulatory, industry, legislative, political and competitor activities to derive appropriate regulatory strategies for product portfolio.
- Support & facilitate launch of new products by liaising with marketing, manufacturing, Finance, Corporate and General Management
- Develop and manage effective working relationships with Health Authorities
- Report quality defective notice to global and monitor project status.

**Medical Affairs**:

- KOL and Medical Society Engagement and Development plus training and scientific education both internally and externally. Specific tasks as follows
- Responsible to Develop KOL and Medical Societies Management Program for the Galderma
- Interact with KOLs and healthcare decision makers at scientific meetings and other forums
- Engages in scientific exchange with KOLs to obtain input on disease landscape, current data, and evidence gaps for Galderma marketed and development stage products
- Tracks treatment guidelines and conduct peer to peer scientific discussions to maintain a reliable presence with KOLs and develop professional relationship.
- Serve as a resource for scientific expert to provide inputs on external medical society collaboration.
- Establishes and maintains professional and credible relationships with KOL key and academic centres
- Partner with academic centres, teaching institutions/universities to develop education programs, trainings and professional development of experts in aesthetic medicine.

**Others**:

- Foster and maintain good cross-functional working relationships with other departments
- Represent the company in the relevant committees of the professional/industry associations, if necessary
- Liaise with Corporate for local Trademarks and other related local legal issues
- Perform any other duties related to Regulatory Affairs and Medical Affairs
- Act as back up LSO (local Safety Officer) and liaise with Quality Assurance Manager

**Requirements**:

- University degree (BS or Master) with medical or life science-related disciplines
- 5 years working experience in regulatory affairs field, preferably with MA experience as well, within an international environment.
- Familiar with Indonesia drugs, medical devices and cosmetics registration procedures and regulatory aspects.
- A good understanding of the commercial drivers of the P

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