Global Regulatory
3 days ago
Join a pioneering team at the forefront of healthcare innovation as a Global Regulatory & Operations Senior Director. Based in the vibrant Cambridgeshire area, this role is a cornerstone within a leading pharmaceutical company, playing a pivotal role in delivering groundbreaking treatments to patients worldwide.
The information below covers the role requirements, expected candidate experience, and accompanying qualifications.
As the Global Regulatory & Operations Senior Director, you will orchestrate the Regulatory Affairs (RA) Operations, steering global regulatory initiatives, refining regulatory systems, and enhancing vendor relationships. Your strategic oversight will ensure that RA operations maintain seamless compliance across the EU and Canada's diverse regulatory environments.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Global Regulatory & Operations Senior Director will be varied however the key duties and responsibilities are as follows:
1. Lead the RA operations, ensuring compliance and efficient delivery across multiple countries.
2. Develop and implement a comprehensive RA data management strategy, fostering data-driven decision-making.
3. Manage the strategic direction of all RA systems, aligning with business goals and financial frameworks. Manage global RA vendor strategy, overseeing performance, compliance and budgetary constraints.
4. Proactively navigate regulatory changes, crafting strategies to optimize operations and mitigate risks.
ROLE REQUIREMENTS:
To be successful in your application to this dynamic position as the Global Regulatory & Operations Senior Director, we are looking to identify the following on your profile and past history:
1. A BSc degree in life sciences.
2. Extensive experience as a regulatory professional.
3. Proven experience in leading Regulatory Operations.
4. In-depth knowledge of regulatory systems, guidelines, and emerging industry trends.
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