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Senior Regulatory Affairs Manager
2 months ago
A Top 10 Pharmaceutical company in Berkshire is seeking a Senior Regulatory Affairs Manager to lead their regulatory strategy and deliverables for a portfolio of early/late development and marketed products in Europe.
- Develop and implement regulatory strategies and deliverables, including effective planning, tracking, and archiving of activities, especially submissions for early/late development and marketed products in the assigned Therapeutic Area.
- Ensure that planned drug development activities comply with Europe Region guidelines and provide critical analysis of risks and issues when necessary.
Requirements:
- Pharmaceutical industry experience in Regulatory Affairs.
- European regulatory experience is essential.
- Experience of Immunology products is beneficial.
- Ability to work effectively across cultures and in complex matrixed environments.
A highly competitive salary, car allowance, annual bonus, private healthcare, and wider benefits are on offer to the successful candidate.