Senior Director, Global Regulatory Compliance and Training - United Kingdom
- Our company is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives.
- Our purpose as a company is to discover and develop therapies that will change the course of human health.
- We value our passion for patients, quest for innovation, spirit of independence and love of challenge.
- With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
To develop, maintain and implement a long-term strategic approach for Global Regulatory Compliance and Training, identifying areas for improvement and ensuring compliance with current regulatory policy, legislation and guidance. Also to identify and, if appropriate, anticipate changes to regulatory policy, legislation and guidance.
- Represent Regulatory Affairs/CORA functions on cross-functional and corporate committees related to compliance, training and associated systems.
- Encourage the development of RAmetrics for communication to Regulatory Leadership to enable their oversight of Regulatory Compliance within the organisation.
- Collaborate with other groups within Regulatory Affairs to ensure that there is appropriate oversight of outsourced activities, (e.g. regulatory Clinical Trial Applications outsourced to Contract Research Organisations).
- Member of the Global Regulatory Governance Committee for outsourced CTA activities.
- Lead the development, timely periodic review / update and implementation of appropriate Standard Operating Procedures (SOPs), Working Practices (WPs), and Best Practices (BPs) within Regulatory Affairs/CORA.
- Provide guidance and direction to procedure authors (SMEs) to ensure the procedure development process, content, format and training assessments comply with RA and Corporate requirements
- Liaise with other departments interacting with Global Regulatory Affairs/CORA including, but not limited to, Drug Safety Risk Management, Clinical Operations, Corporate Quality and Compliance, Clinical Quality, Medical Affairs, and Regulatory Affiliate roles to ensure appropriate cross-functional SOPs, WPs, and BPs are in place.
- Liaise with Drug Safety department to ensure the Pharmacovigilance System Master File (PSMF) is updated following related changes in RA SOPs and WPs.
- In collaboration with the appropriate Regulatory Leadership Teams, provide support to appropriately address any procedural deviations or compliance issues relating to regulatory involvement documented processes, including tracking the progress of completion of any associated Corrective and Preventative Actions (CAPAs).
- Design and maintain a role-based procedure training curriculum. Make curriculum recommendations to Global Regulatory Leadership Team and Regional Regulatory Leadership Team as appropriate. Analyze training requirements for new and updated procedures. Manage / oversee implementation of the curriculum in company’s learning management system.
- Liaise with RA procedure authors / SMEs to provide training to RA personnel on procedures as needed.
- Assess global needs for training on non-procedural regulatory topics; design associated training curriculum; work with SMEs to develop training sessions.
- In collaboration with Global Regulatory Affairs Leadership Team and Regional Regulatory Leadership Team where appropriate, ensure that training records are set-up and maintained for RA colleagues and those records are appropriately retained for Audit and Inspection purposes.
Audits and Inspections
- In collaboration with the Global Regulatory Affairs Leadership Team and Regional Regulatory Affairs Leadership Team as appropriate, contribute to company strategy for regulatory inspections, where Regulatory Affairs is involved.
- Lead preparation for, coordination during and subsequent follow-up activities for GxP audits and inspections related to Global Regulatory activities and communicate with Global Regulatory Affairs Leadership Team and Regional Regulatory Affairs Leadership as appropriate, on global regulatory-related compliance activities within the company.
- In collaboration with the Global Regulatory Leadership Team maintain a system for recording and tracking the progress of completion of any agreed Corrective and Preventative Actions (CAPAs).
- Review all findings related to Regulatory Affairs activities in internal GxP audit and regulatory inspection reports and ensure CAPAs are implemented in a timely fashion. Where appropriate, recommend CAPA actions for the Regulatory functions in the Affiliates.
Regional Management Team
- Ad hoc member of the EMEA Regulatory Affairs Project Leadership Team.
- Oversee Regulatory Compliance & Training personnel.
- Lead the performance review process for direct reports; conduct performance evaluations, promotion recommendations, and other related adjustment information.
- Serve as a resource and mentor.
- Oversee training and development of staff and appropriate documentation of position requirements.
- Bachelor’s degree or equivalent in scientific discipline or life science.
- Significant pharmaceutical industry experience, including experience in a compliance-related role, to include work with either a regional or a global remit.
Skills and Knowledge requirements
- Good understanding of the drug development process and the post-marketing environment and also the interdependencies between different departments involved.
- Experience in creating and managing Standard Operating Procedures and understanding of quality management systems.
- Experience in training administration.
- Understanding of GxP Regulatory Inspection processes and requirements. Considers and incorporates global perspectives and requirements
- Good knowledge of US and European Regulations.
- Excellent facilitation, negotiation and networking skills and a strategic understanding of different functional teams.
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously. Communicates effectively at all levels
- Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail.
- Occasional International travel may be necessary.