- Provide strategic regulatory directions to the country leadership team. Accountable for delivering project goals and aligning functional strategies with business needs.
- Take on the So-katsu role for cosmetics and quasi drug products to fulfil the local regulatory requirements.
- Lead and manage locally the regulatory operations for cosmetics and quasi drugs in ensuring the appropriate regulatory approvals and/or product marketing authorizations are obtained timely.
- Define regulatory priorities in line with the business priorities and embed functional capabilities to enable growth.
- Maintenance of existing product licenses for Galderma's growing portfolio and ensuring regulatory compliance at all times.
- Provide appropriate input on the development of new products and shaping of the local regulatory environment.
- Lead the cosmetics and quasi drugs 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.
- Ensure high quality and timely submissions. Prepare and submit regulatory affairs applications such as new product registrations and variations across the assigned regulatory product classes to meet country's business objectives and timelines. Facilitation of all aspects of these applications including submission, responses to questions and negotiations with the Health Authority.
- As Sokatsu for cosmetics and quasi drugs, perform regulatory maintenance of registered products (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.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
- Review and approve promotional and non-promotional materials including product labelling, ensuring their compliance with local regulations, code of conduct and internal guidelines; suggest alternatives when necessary. Coordinate review with the responsible functions in the country. Ensures consistency and conformity to the various published guidelines.
- Ensure that progress of applications and changes to registered details are communicated timely and regularly to local and global stakeholders.
- Review proposed product labels for regulatory assessment and submit to register label changes to the relevant health authority if needed 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.
- Ensure required business licensing related to marketing/distribution of health products are obtained and maintained accordingly.
- Develop, implement and manage appropriate regulatory SOPs, WIs and other processes as required to address the gap between global policy and regional regulatory requirements.
- Keep abreast of relevant regulatory, industry, legislative, political and competitor activities to derive appropriate regulatory strategies for product portfolio as well as to communicating it to the relevant stakeholders.
- Compliance:
- Support company's compliance program related to cosmetics and quasi drugs, promote and ensure compliance with global guidelines, local laws and regulations and foster a culture of integrity.
- Monitor & maintain compliance to corporate standards and local regulations on interactions with healthcare professionals (HCP)
- 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 trade compliance issues in relation to cosmetics and quasi drugs.
- Helps to ensure any non-compliance related to cosmetics and quasi drugs is documented with proposed CAPA(s) and oversees that all CAPAs are resolved.
- Adhere to related laws, regulations, Galderma Code of Ethics, and any other applicable Codes and SOPs.
- Minimum of 8 years of hands-on experience in regulatory affairs within cosmetics and quasi drugs industry
- Experience working in an international matrix organisation
- Good working knowledge of cosmetics and quasi drugs registration procedures and regulatory aspects in Japan
- Experience leading end-to-end new product registration for cosmetics and quasi drugs
- Experience with leading PMDA meetings
- A good understanding of the commercial drivers of the cosmetics and quasi drugs industry and an associated ability to provide advice/guidance that takes these into consideration
- Analytical skills and attention to detail with the capability to appropriately define issues, questions and data
- Excellent communication skills: good, positive and proactive communication and the ability to foster excellent working relations with both internal & external customers including the HA, Industry Associations and internal stakeholders
- Skills such as project management, problem solving, ability to present information in easily understood format at internal and external meetings, good time management, negotiation and interpersonal skills
- Ability to work both independently – hands-on - or as part of a team as required
- Be able to balance company commercial needs with compliance requirements
- Ability to think strategically and innovatively for resolution of regulatory issues, envisioning the future and deciding on strategic priorities
- Commitment to continued improvement in department processes and performance
- Be a self-starter and proactively contributes to a positive team attitude and highly productive work environment
- Driving excellent execution and consequently delivering results
- High level of integrity and credibility
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Regulatory Affairs Manager - Tokyo, 日本 - Galderma
説明
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we're in shapes our lives, we are advancing dermatology for every skin story.
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 promote their personal growth 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 bold 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 an unparalleled, direct impact.
Key attributes of the role:
Strong regulatory leadership will be crucial to navigate the regulatory environment and the demanding specific regulatory requirements in Japan. This role requires regulatory experience in leading end-to-end development and marketing authorisation applications for new cosmetics and quasi drugs, as well as experience in leading interactions with the respective health authorities.
Core Mission:
Regulatory Affairs:
Education/Training:
Bachelor's Degree preferably in Pharmacy or Life Science subject. Master's degree would be an added advantage.
Work Experience:
Language: Proficiency in written and spoken English
Required pre-requisites skills/experience for this position:
