Regulatory Affairs Specialist
4 weeks ago
About the Role:
Thornton & Ross, a leading producer of household pharmaceutical products, is seeking an experienced Regulatory Affairs professional to join its dynamic team. As a key member of the Regulatory function, you will take ownership of a portfolio of diverse projects, help strengthen ways of working in the team and with business partners, and support the development of colleagues within the Regulatory function.
Key Responsibilities:
- Work with key partners across the business as the Regulatory lead on high-profile licensed medicines projects, including NPD and key maintenance initiatives.
- Support new and existing product maintenance by preparing comprehensive regulatory strategies, aligning stakeholders, and delivering projects in line with agreed business plans.
- Engage with regulatory authorities and trade associations.
- Perform dossier review/gap-analysis in support of product acquisition.
- Prepare and submit dossiers to achieve timely authority approvals.
- Provide Regulatory support on our Biosimilars and Speciality product portfolio.
About You:
We value diversity and uniqueness at STADA, and we recognize our differences as a strength. Our values, Entrepreneurship, Integrity, Agility, and One STADA, ensure our uniqueness thrives, enabling us to care for people's health as a trusted partner. If you're keen to add value and see results, and enjoy working in a fast-paced environment, we encourage you to apply.
Requirements:
- A relevant Life Sciences Degree or substantial experience.
- Several years of solid medicines Regulatory work experience, including managing the registration and life-cycle management of product files.
- Experience with document management systems, publishing software, and licensing databases/submission portals.
- A self-starter who can work on their own initiative with strong project management skills.
- Well-developed understanding of commercial drivers and regulatory strategies and registration routes.
- Strong communication and influencing skills and able to partner effectively with a wide variety of global stakeholders.
What's in it for you?
We offer a range of fantastic benefits, including an opportunity to further develop your medicines Regulatory experience, a recently renovated work environment, 25 days annual leave, hybrid working options, and more.
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