Head of Regulatory Affairs
2 weeks ago
As the Head of Regulatory Affairs for the United Kingdom and Ireland, you will be responsible for leading and managing all regulatory activities to ensure compliance with applicable laws, regulations, and guidelines governing our organization's products and operations within these regions. This role requires a deep understanding of regulatory requirements in both the UK and Ireland, excellent leadership skills, and the ability to collaborate effectively across departments and with regulatory agencies in both countries.
Key Responsibilities:
- Regulatory Strategy Development: Develop and implement regulatory strategies aligned with business objectives for products in the UK and Ireland markets. Stay informed about changes in regulatory requirements and proactively adjust strategies as needed.
- Regulatory Compliance: Ensure that all products, processes, and activities comply with relevant UK and Irish regulations, standards, and guidelines. Monitor regulatory developments and assess their impact on the organization.
- Regulatory Submissions: Oversee the preparation, submission, and maintenance of regulatory submissions to UK and Irish regulatory authorities, including marketing authorization applications, variations, and renewals.
- Regulatory Intelligence: Stay abreast of regulatory trends, competitor activities, and industry best practices in the UK and Irish regulatory landscapes. Use this intelligence to inform decision-making and provide strategic guidance to senior management.
- Cross-Functional Collaboration: Collaborate closely with internal stakeholders, including R&D, Quality Assurance, Legal, and Commercial teams, to ensure regulatory requirements are considered throughout the product lifecycle.
- Agency Interactions: Serve as the primary point of contact for interactions with UK and Irish regulatory agencies. Represent the organization in meetings, negotiations, and communications with regulatory authorities.
- Risk Management: Identify regulatory risks and develop mitigation strategies to address them. Provide guidance on risk assessment and management to ensure compliance and minimize regulatory issues.
- Training and Development: Provide leadership, guidance, and mentorship to regulatory affairs team members. Conduct training sessions to ensure awareness of regulatory requirements and foster a culture of compliance within the organization.
- Quality Management Systems: Collaborate with Quality Assurance to maintain and improve the organization's quality management systems, ensuring alignment with regulatory requirements and industry standards.
- Audit and Inspection Readiness: Prepare the organization for regulatory inspections and audits conducted by UK and Irish regulatory authorities. Coordinate responses to inspection findings and implement corrective and preventive actions as necessary.
Qualifications:
- Bachelor's degree in a scientific discipline; advanced degree preferred.
- Extensive experience (10+ years) in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry, with a focus on the UK and Irish markets.
- Oncology experience is beneficial.
- Demonstrated expertise in UK and Irish regulatory requirements and processes, including experience with MHRA and HPRA submissions and interactions.
- Strong leadership skills with experience managing teams and leading cross-functional projects.
- Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders.
- Strategic thinking and problem-solving abilities, with a proactive approach to regulatory challenges.
- Familiarity with quality management systems and regulatory compliance frameworks (e.g., GMP, GDP, GCP).
- Ability to thrive in a fast-paced, dynamic environment and effectively prioritize competing demands.
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