Director, UK & EU Compliance Officer

at  Autolus Ltd

DEMONSTRATED SKILLS AND COMPETENCIES

E – Essential P – Preferred

EXPERIENCE

• Significant level of compliance & ethics experience in the life sciences industry, with demonstrated and progressive experience (P)
• Experience implementing GDPR requirements (E)
• Experience negotiating DPAs (E)
• Experience with cell or gene therapy compliance issues (P)

QUALIFICATIONS

• Bachelor’s degree or equivalent (E)
• Legal experience or qualifications in the UK or the EU (P).

SKILLS/SPECIALIST KNOWLEDGE

• Experience developing and implementing effective compliance programs in the life sciences industry (E)
• Knowledge of compliance regulations in one or more European jurisdictions where the Company operates (currently the UK, Germany & Switzerland) (P)
• Understanding of the pharmaceutical industry with expertise in applicable laws and regulations (E)
• Ability to work effectively with a variety of stakeholders, both internal and external (E)
• Excellent interpersonal, oral & written communication skills; experience writing and presenting to diverse audiences, including the company’s board of directors (E)
• Ability to influence behaviour, and proactively identify potential problems (E)
• Be business oriented and solution-driven (E)
• Willingness to move at a fast pace and drive efficiencies (E)
• Proficiency with Veeva Promomats, MS Office and with common remote work tools, including videoconferencing, Sharepoint, and other cloud-based services (E)

ROLE SUMMARY

The Director, EU & UK Compliance Officer is responsible for developing, implementing, and managing the organization’s EU & UK compliance and privacy programs to ensure compliance with relevant laws, regulations and global policies. This role involves overseeing compliance with laws, regulations and codes relevant to the biopharmaceutical industry, including but not limited to GDPR, UK GDPR, EMA regulations, MHRA regulations, ABPI, EFPIA and IFPMA. The Director will work closely with various departments to ensure compliance protocols are followed and will act as the primary contact for UK and EU personnel on compliance and privacy related matters.
The Director will provide support to the Vice President, Compliance & Privacy Officer and wider legal team and will assist with implementation and management of the company’s compliance program. They will work with senior executives and other stakeholders within the company to develop policies, manage training, review & approve promotional and medical literature, conduct compliance-related investigations to ensure compliance with relevant laws, regulations and standards.

KEY RESPONSIBILITIES

• Develop, implement, and maintain comprehensive compliance programs and policies.
• Ensure the organization complies with all applicable laws and regulations.
• Advise on data privacy regulations and requirements and develop policies required to ensure compliance, including DPAs and acting as the DPO for the UK.
• Conduct regular compliance risk assessments and audits to identify potential areas of vulnerability in line with cell therapy development and commercialization.
• Support the team for MLR reviews (via Veeva Promomats).
• Monitor changes in relevant EU & UK laws and regulations and update compliance programs accordingly.
• Prepare and submit compliance reports to regulatory bodies as required.
• Maintain effective communication with regulatory agencies and manage all inquiries and investigations.
• Support the team to develop and conduct compliance training programs for employees at all levels.
• Ensure all staff are informed of their responsibilities under the compliance program.
• Provide ongoing education and resources to keep the organization current on compliance best practices.
• Oversee and investigate compliance-related incidents and breaches.
• Develop and implement corrective action plans to address compliance issues.
• Maintain documentation of all compliance activities and investigations.
• Support the Vice President with running a Compliance Committee and collaborate with department heads to promote a culture of compliance.
• Provide guidance and support to senior stakeholders on compliance-related matters.
• Serve as a liaison between the organization and external auditors and regulators.