Senior Director, Regulatory Affairs - Regulatory Team Lead
PPD has an exciting new vacancy for a Senior Director within the Regulatory Affairs Department. This is a key leadership role in which you will have the opportunity to leverage your breadth of experience together with your proven strategic and leadership background, and take your Regulatory Affairs career to the next level.
The purpose of the role is to provide innovative solutions including global regulatory therapeutic area expertise and client interface, to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization. In addition, you will lead a strong and dynamic team, and growing business unit.
In this role, you will: - Provide regulatory consulting and strategic advice to internal and external clients
- Provide technical expertise and co-ordination oversight for key clientrojects
- Liaise with PPD globally to support global projects, and ensure quality performance for key/managed projects
- Serve as key clients cutiventact person for all issues including attendance at Regulatory Authority meetings and other Public Relation functions
- Manage project budgeting/forecasting
- Assist business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure
- Establish policies appropriate for the function, interprets and recommends modifications to company-wide policies and practices, develops and is responsible for budgets, schedules, and performance standards.
- Line management responsibilities for a team of 5-6 senior level staff, which may be located across multiple regions
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Qualifications Education and Experience: - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ yearsr equivalent combination of education, training, & experience
- Excellent and proven, leadership and line management skills
- Expertise with ATMP/Gene Therapy, Medical Devices, or Vaccines would be advantageous
- CRO/Consulting and customer facing experience is desirable
- Strong regulatory strategy background and full understand of end to end drug development process.
Knowledge, Skills and Abilities: - Proven experience in business development activities and networking
- English language as well as local language where applicable
- Excellent interpersonal skills
- Familiar with computers and their applications, e.g. Word, Excel, PowerPoint
- Effective oral and written communication skills
- Excellent organizational and planning skills
- Excellent negotiation skills
- Ability to work on own initiative
- Proven ability to work effectively in a team environment
- Ability to motivate and integrate teams and teach/mentor team members
- Good knowledge of global / regional / national country requirements / Regulatory Affairs Procedures for Clinical Trial Authorization, licensing, lifecycle management
- Expert knowledge of ICH and other global regulatory guidelines
- Ability to discipline and reward employees and perform timely, effective performance evaluations
- Good judgement and decision-making skills
- Ability to act as liaison with other departments where necessary (i.e. Project Management, Clinical Supplies, QA, Clinical Management, Data Management, Biostatistics, etc)
Working Conditions and Environment:
- Work is performed in an office environment with exposure to electrical office equipment.
- Occasional drives to site locations, frequent travels both domestic and international.
Physical Requirements: - Frequently stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Moderate mobility required.
- Occasional crouching, stooping, bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others, relates sensitive information to diverse groups both internally & externally.
- Ability to apply abstract principles to solve complex conceptual issues. Requires multiple periods of intense concentration.
- Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
