Assoc Dir, Reg Consulting Bardi

Assoc Dir, Reg Consulting
Bardi
Emilia Romagna, Bardi

JOB SUMMARYResponsible for the effective and efficient management of regulatory projects and functions under assigned span of control.

Responsible for the leadership and management of regulatory personnel and assuring that the various departmental tasks are completed in conformity with all the policies, Standard Operating Procedures, directives, and governmental regulations.

Contributes to business development for regulatory functions, planning of staff and locations, and budgets; develops goals objectives, plans, and procedures, in conjunction with the senior management.

JOB RESPONSIBILITIES Contributes to planning for regulatory submissions in assigned region/country/project.

Responsible for day-to-day management of project teams and projects.

Line management responsibilities for staff members.

For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.

Approves courses of action on salary administration, hiring, corrective action, and terminations.

Reviews and approves time records, expense reports, requests for leave, and overtime.

Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.

Acts as a representative of the regulatory department with other departments.

Supports business development, including generation of repeat business from existing clients and proposal development.

Develops, reviews, and monitors project budgets, reviews client invoicing.

Monitors personal utilization and utilization of direct reports.

Acts as a key point of contact for clients and regulatory authorities.

Provides regulatory advice to Company associates.

Prepares consulting reports.

Provides strategic and operational advice to clients.

Arranges, leads, and reports on client and regulatory agency meetings.

Writes IND and product registration dossiers, clinical reports, and other regulatory documents.

Manages project teams and preparation of regulatory submissions for conduct of INDs, product registrations, and post approval maintenance activities. Contributes to the development of policies, goals, objectives, plans, and procedures for functions under assigned span of control.

Acts as a resource for technical knowledge.

Participates in quality improvement efforts to increase overall operational efficiency.

Contributes to the building of regulatory systems and infrastructure needed for GRAS.

Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees.

Develops solutions to complex problems.

Provides internal training in appropriate areas of expertise to other departments.

Other Responsibilities:

Performs other work-related duties as assigned.

Minimal travel may be required (up to 25%).

QualificationsQUALIFICATION REQUIREMENTS BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field or moderate pharmaceutical/medical device related experience.

Moderate experience in regulatory.

Demonstrated experience in contributing to the preparation of regulatory submissions including for example IND, PMA, NDA, MAA, and CTD, including electronic submissions.

Experience in niche submissions such as ODD, PIP/PMP an advantage.

Comprehensive regulatory knowledge and understanding of pharmaceutical and or medical device product development.

Excellent interpersonal / communication skills including excellent written and verbal communication skills.

Excellent customer service skills, with the ability to work both as a team member and independently.

Good quality management and budgeting skills.

Good people management, project management, problem-solving, and decision-making skills.

Advanced skills in Microsoft Office Applications.

Ability to interact with staff from multiple departments and offices to establish project standards.

Good initiative, adaptability, and pro-activity.

Strong analytical skills, good attention to detail.

Ability to work concurrently on projects, each with specific instructions that may differ from project to project.

Fluent in speaking, writing, and reading English.