Manager, Regulatory Affairs

The Manager within R&A provides leadership and direction to Associates, Consultants and Senior Consultants, actively managing employee performance and development. Additionally acts as a role model and provides or organizes coaching/mentoring and feedback to direct reports. Provides a broad range of consulting services and works within broad project guidelines to identify, refine, and address client issues and to achieve project objectives.
Interested candidates in the Regulatory Line Manager from Mexico, DC (at least 3 or 4 years of experience) leading large teams.

The Regulatory Affairs Manager works within a team environment or individually based on the project needs, such as:

• Provides guidance to project team members.
• Works within broad project guidelines and facilitates issue and conflict resolutions.
• Prioritizes own workload and may prioritize the workload of the project team in order to achieve the project scope and objectives.
• Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action.
• Leverages information from previous projects or other client work to
• efficiently complete assigned project activities as well as facilitate business decisions.
• Produces quality work that meets the expectations of PC and the client.
• Reviews the work of colleagues for content and quality to ensure the
• expectations of the client and PC are met.
• Assesses project issues and develops strategies to meet productivity,
• quality and project goals and objectives.
• Manages project engagements as a project lead (small or medium).
• Actively manages performance including typical HR activities for direct reports (i.e. performance management reviews, salary actions, bonuses,
• scorecards).
• Provides input on staff to appropriate PC Directors.
• Provides applicable guidance and support to staff in order for staff to
• succeed and achieve key metrics.
• Supports development plans for staff and coordinates with senior management to ensure that staff is utilized completely and appropriately to
• increase their expertise.
• Meets established metrics as specified in scorecard on an annual basis.
• Completes basic job-related responsibilities, including timesheets, expense,
• reports, maintenance of CVs, project deliverable archiving, participation in
• internal initiatives/projects or as a mentor as requested by management.

General skills and experience:

• Deep knowledge of the Clinical trial regulation in Mexico and all related processes with the COFEPRIS regarding Clinical trials and marketing application of drugs (this last one is nice to have).
• Consulting skills and project management knowledge.
• Influencing others add teamwork and collaboration.
• Client-focused approach to work.
• Networking and results orientation.
• Business analysis.
• Excellent interpersonal and intercultural communication skills, both written and verbal.
• Critical thinking and problem-solving skills.
• Holding people accountable.
• Operational leadership and leading change.
• Proficiency in local language and extensive working knowledge of the English language.