Associate Director, European Regulatory Affairs
Veristat is expanding our presence internationally from our home office outside Boston to Montreal, Toronto, Research Triangle Park, Michigan, Taiwan, and most recently the United Kingdom.
We do things differently than large CROs. Do you value scientific integrity and a collaborative team environment? If so, you will feel right at home here with dedicated opportunities to discuss your achievements and grow your career through quarterly managerial conversations.
We invite you to learn more about us at our website www.veristat.com.
The Associate Director, European Regulatory Affairs is charged with the primary task of effectively managing the European Regulatory Affairs team, overseeing the Regulatory aspects of projects and project teams through the management of internal staff, department managers, and interaction with Executive-level staff. S/he is responsible for the maintenance of optimal department processes, the implementation of project-specific strategies, and the development and implementation of department strategies to increase productivity and quality.
The Associate Director, European Regulatory Affairs develops and maintains a close relationship with client contacts, project managers, and department managers to drive the Regulatory aspects of project delivery. S/he also provides oversight of project-related Regulatory Affairs tasks and contributes to project-related tasks as required while adhering to Veristat SOPs.
As an Associate Director, EU Regulatory Affairs you will…
- Be responsible for the direct management of European Regulatory Affairs managers and assigned staff, and indirect management of all European Regulatory Affairs staff including performance management, career development, training, and employee relations
- Be responsible for resourcing and project staffing, with support from Leadership. Therein, assist with assessing hiring needs, interviews, compensation, and hires to align with the needs of the department
- Participate in the creation and provision of strategic direction and leadership to the European Regulatory Affairs department to best achieve departmental and company goals. In conjunction, s/he also participates as a member of the Senior Leadership Team
- With support from Leadership, be responsible for Department financials - profit and loss (P&L), including participation in corporate revenue recognition activities and senior leadership meetings related to European Regulatory Affairs
- Represent European Regulatory Affairs in business development activities by developing project bid proposals, participating at bid defense & governance meetings, performing client presentations, and participating in external events to elevate Veristat’s industry presence, to act as a thought leader
- Ensure that relevant Regulatory Affairs project responsibilities are completed in an accurate and timely manner, consistent with Veristat or client SOPs and with high quality, through use of staff
- As needed, participate in project management activities, including attendance and oversight for internal project review meetings, and working with Veristat Project Managers to ensure that relevant Regulatory Affairs projects are completed within budgetary constraints of applicable client contracts or work orders
- Contribute to the continuous improvement of the department; bring efficiencies and best practices to the organization
- Support the development and implementation of Regulatory Affairs Standard Operating Procedures (SOPs), guidelines, policies, procedures and clinical database functional requirements and ensure personnel are trained appropriately
- Oversee the implementation and management of relevant Regulatory systems and vendors. Evaluate process improvements and innovative methods for Regulatory Affairs in collaboration with cross-functional teams
- Collaborate with all other department functional heads & client peers
- Facilitate communication and promote teamwork among team members
- Maintain up-to-date, relevant knowledge of clinical drug development and Regulatory Affairs to effectively serve as a department resource
- Lead by example and models core values in all actions; ensure a positive, respectful team environment, fostering collaboration and development
Experience + Requirements
- Bachelor’s Degree in a related field, with a minimum of 8 years of directly related European Regulatory experience in a CRO, with at least 5 years of supervisory experience required
- Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research required
- Demonstrated ability to lead by example, and demonstrated skill for technical and supervisory leadership of staff required
- Excellent written and oral communication skills including grammatical/technical writing skills and presentation skills required
- Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical/biotech companies required
- Excellent interpersonal, communication, and organizational skills with the ability to work independently as well as in a team environment required
- Experience interacting with regulatory agencies, such as the EMA or CDRH, strongly preferred