Associate Director Regulatory Compliance and Training

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Responsibilities

Support the creation, development, maintenance and implementation of the long-term strategic approach for Global Regulatory Compliance

Identify and monitor key performance indicators, areas of improvement and ensuring compliance with current regulatory policy, legislation and guidance

Identify and, if appropriate, anticipate changes to regulatory policy, legislation and guidance impacting global regulatory procedures

Lead on identified process improvement initiatives, as required

Procedural Documents

Lead the development and implementation of strategy for and timely periodic review/ update and implementation of appropriate Standard Operating Procedures (SOPs) and Working Practices (WPs) within Global Regulatory Affairs (GRA)

Provide guidance and direction to procedure authors/SMEs to ensure the procedure development process, content and format comply with GRA and Corporate requirements

Partner with other departments interacting with Global & Regional Regulatory Affairs including, but not limited to, Global Drug Safety & Risk Management, Global Clinical Research Development Operations, Global Compliance, Clinical Quality Assurance, Medical Affairs to ensure appropriate cross-functional SOPs and WPs are in place

Liaise with Global Drug Safety department to ensure the Pharmacovigilance System Master File (PSMF) is updated following related changes in GRA SOPs and WPs

Chair Global Regulatory Compliance SOP review meetings

Manage GRA procedural deviations – planned and unplanned

Represent GRA on Corporate training initiatives

Training Administration

Lead the tracking of GRA and applicable cross-functional SOPs in departmental database

Provide input into the design and maintenance of a role-based training curriculum. Make curriculum recommendations, analyses training requirements for new and updated procedures

Partner with GRA procedure authors/SMEs to provide training to GRA personnel on procedures as needed

Assess regional needs for training on non-procedural regulatory topics; design associated training curriculum; work with SMEs to develop training sessions

Manage GRA employee training records for Audit and Inspection readiness

Audits and Inspections

Contribute to company strategy for internal audits and regulatory inspections, where Global Regulatory Affairs is involved

Responsible for preparation, coordination during and subsequent follow-up activities for GvP (and GxP where required) audits and inspections related to regulatory activities globally

Lead the maintenance of a system for recording and tracking the progress of completion of any agreed Corrective and Preventative Actions (CAPAs) and, be responsible for ensuring GRA actions are tracked to completion

Review all findings related to Global Regulatory Affairs activities in internal GvP (and GxP where required) audit and regulatory inspection reports and ensure CAPAs are implemented as appropriate

Skills/knowledge Required

Bachelor’s degree or equivalent in scientific discipline or life science

Minimum of 10 years pharmaceutical industry experience, including experience in a compliance or regulatory affairs role, to include work with either a regional or global remit

Good understanding of the drug development process and the post-marketing environment and the interdependencies between different departments involved

Minimum of 5 years’ experience in creating and managing Standard Operating Procedures and solid understanding of pharmaceutical industry quality management systems

Minimum of 5 years’ experience in training administration

Solid understanding of GxP Regulatory Inspection process and requirements

Good knowledge of global regulatory requirements

Strong facilitation, negotiation and networking skills and a strategic understanding of different functional teams

Strong organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously

Must be able to innovate, analyse and solve problems with minimal supervision and attention to detail

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com