Description
Mgr, Regulatory Consulting (Portfolio Management -EU)
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities
Works independently to formulate and lead regulatory strategy for a portfolio of products. Manages end-to-end regulatory lifecycle activities such as new MAAs, renewals, RA/CMC variations, HAQs, annual reports, xEVMPD activities, site renewals/GMP clearances, periodic safety reports and safety updates for global markets with extensive experience in EU procedural submissions.
Acts as a representative of the regulatory department with other departments. Manages liaison with cross functional teams and acts as the point of contact for client counterparts. Provides strategic and operational advice to clients.
Acts as a key point of contact for client and regulatory authorities. Arranges, leads, and reports on client and regulatory agency meetings.
Responsible for day-to-day management of project teams and projects. Provides regulatory advice to junior team members.
Participates in quality improvement efforts to increase overall operational efficiency. Lead process improvement initiatives for client projects.
Develops solutions to complex problems. Acts as a resource for technical knowledge.
Robust risk identification, mitigation and escalation. Provide resolution for all kind of risks.
Appreciable experience in RIMS/DMS preferably Veeva.
Provides internal training in appropriate areas of expertise to junior team members and other departments.
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.
Monitors personal utilization and utilization of direct reports.
Supports business development, including generation of repeat business from existing clients and proposal development.
Conducts regulatory research on projects as needed.
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.
Other Responsibilities:
Performs other work-related duties as assigned.
QUALIFICATION REQUIREMENTS
Master’s degree in pharmaceutical sciences
Above 10 years of demonstrated experience in end-to-end portfolio management for drug products with Subject matter expertise in managing EU markets
Comprehensive regulatory knowledge and understanding of pharmaceutical 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.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Responsible for leadership of major assignments and client relationships. Responsible for organizing and managing project teams and for the quality and timeliness of assignments. Provides advice and assistance to clients and other associates in areas of expertise. Ensures that the various project related tasks are completed in conformity with all Company policies, Standard Operating Procedures, and governmental regulations. Contributes to business development for regulatory functions.
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