Regulatory Affairs Manager

2 days ago

กรงเทพมหานคร, Thailand 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.

**Job Description**:
An exciting opportunity for a Regulatory Affairs Manager to look after our Aesthetics and Prescription Businesses. This is a pivotal role within Galderma and will see you work closely with our JPAC and Global Regulatory Affairs Stakeholders whilst working with the TGA to ensure, Category 1 Variations are aligned with the regulatory requirements.

This is the ideal role for someone looking for the next transition in their Regulatory Affairs career and to move from one of the larger Medical Devices, Pharmaceutical or BioTech companies into a role with a broader degree of scope and global stakeholder engagement. This role will polish your commercial acumen and progress your career to the next level.

The duties in this role will involve:
- Provide input to and lead the implementation of Regulatory Affairs Generalists' plans and programs to analyse and manage regulatory activities on both new and in-line products in following TGA / Health Authorities to define registration strategy and planning.- Research and evaluate the Regulatory Affairs Generalists' policies, monitoring their deployment and achievement to enhance the effectiveness of Regulatory Affairs Generalists' strategies.- Prepare Regulatory Affairs Generalists' plans and policies to translate current/ future business needs and challenges into effective Regulatory Affairs Generalists plans for Galderma.- Execute Regulatory Affairs Generalists plans related to regulatory activities on both new and in-line products following TGA health guidelines to define registration strategy and planning along with policies to build all the aspects of the product safety and fulfil the regulatory requirements- Prioritise and coordinate transformation and change of Regulatory Affairs Generalists policies and processes if required organising the preparation, submission and follow-up of medical affairs and authorities (MAA) and registration files- Understand and analyse ongoing Regulatory Affairs Generalists processes Monitoring/interpreting regulatory developments and determining the impact on business operations and compliance programs and implementation, identifying any need for improvement and implementing programs and policies that better suit the needs of Galderma- Develop and formulate compliance with legislation and regulations of the business- Coordinate key Regulatory Affairs Generalists' activities reporting and documenting them for internal and external audiences- Guide and consult Galderma employees gathering data, preparing, reviewing, and/or approving regulatory compliance documents with a focus on strategic and operational Regulatory Affairs Generalists activities- Establish and maintain a potential relationship with all stakeholders within and outside the organisation

You are a Regulatory Affairs Specialist with experience working with Category 1 Variances with the TGA. You are driven, commercially astute, and looking for a role that will challenge you and refine your stakeholder engagement capability. This is a fast-paced role. We are looking for someone agile and nimble in their approach, yet highly organised and who understands how to manage complex processes.

You will have a Bachelor's Degree in Science, and experience working in Biotechs, Pharmaceuticals or Life Sciences is preferable. You must have at least 5 + years working in Regulatory Affairs and Category 1 variance Prescription experience.

What is in it for you?

By joining us, you'll be able to further your career in an environment that promotes personal initiative. You can share the pride of helping to develop high-quality products that make a difference in people's health, well-being and lives in general. You will be joining a company with a rich history and great brands, a unique culture and an excellent working environment. We will allow you to develop personally through meaningful work that helps you transform your passion and innovative ideas into action and results. In addi

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