Reg Affairs AD, FSP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summarized Purpose: 
Manages a large, regional and/or global team of staff and managers within the department and provides 
innovative solutions including regulatory expertise and client interface to provide strategic regulatory 
intelligence and guidance for product development from preclinical through registration and product 
optimization. Manages projects and participates in strategic initiatives. Acts as liaison with internal and 
external clients in the provision and marketing of regulatory services.
Essential Functions and Other Job Information: 
Essential 
Functions
 Manages staff, which may include interviewing and selection, job description 
preparation, professional development, goal setting, performance management, 
behavioral and technical 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. Promotes all aspects of PPD Equal 
Employment Opportunity policy and Affirmative Action Plan. Assures department 
adherence to good ethical and regulatory standards.
 Provides regulatory consulting and strategic advice to internal and external 
clients to determine the most appropriate regulatory and product development 
strategy for their products. Provides project specific strategy, technical expertise 
and coordination oversight for key client’s projects. Serves as the executive 
contact for key clients for all issues, including attendance at regulatory authority 
meetings and other public relation functions. Ensures quality performance for 
key/managed projects.
 Manages project budgeting/forecasting to include creative input as to shifting of 
resources, allocations etc. to respond to a change in scope of personnel 
requirements to stay within project budget. Leads and participates in project 
meetings.
 Ensures identification of out of scope activities in a contract in a timely manner 
and liaises with other departments to follow through on all aspects of contract 
modification.
 Collaborates with 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 with the client and BD.
 Contributes to development and implementation of global/regional 
function/plans.
 Ensures compliance with relevant organizational and department SOPs and 
WPDs
 Creates and leads the development and implementation of processes and 
procedures to increase productivity and accuracy within the team. Participates 
in developing and implementing systems and tools to continually improve 
efficiency of all activities supporting and facilitating process improvementsreduction in cycle times, submission activities, metrics and other key 
performance indicators.
Policy & 
Strategy
Establishes operating policies & procedures that affect departments and subordinate 
sections of work units. Interprets company-wide policies and procedures. Develops 
budgets, schedules, and performance standards.
Freedom to Act Assignments are objective oriented. Work is reviewed in terms of meeting the 
organization's objectives and timelines.
Liaison Interacts frequently with internal and external management and senior-level 
customer representatives concerning projects, operational decisions, scheduling 
requirements, and / or contractual clarifications. Leads briefings and technical 
meetings for internal and external representatives.
Qualifications: 
Education and Experience: 
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 
10+ years).
5+ years of management responsibility
Proven leadership skills
In some cases an equivalency, consisting of a combination of appropriate education, training 
and/or directly related experience, will be considered sufficient for an individual to meet the 
requirements of the role. 
Knowledge, Skills and Abilities: 
 Effective English language communication and negotiation skills, as well as local language where 
applicable, both oral and written 
 In-depth understanding of global/regional/national country requirements and regulatory affairs 
procedures for clinical trial authorization, licensing and lifecycle management
 Broad understanding of ICH and other global regulatory guidelines
 Advanced knowledge of at least one of the regulatory speciality areas: preclinical, clinical, CMC, 
publishing, etc.
 Advanced understanding of budgeting and forecasting with the ability to interpret data with attention 
to detail and analytical and investigative skills
 Capable of supervising, evaluating, and mentoring departmental personnel
 Capable of delegating tasks and facilitating the completion of assignments
 Capable of driving innovation in developing new ideas related to process improvements
 Comprehensive organizational, judgment, analytical, decision-making and interpersonal skills to 
manage complex projects in parallel and manage rapidly changing priorities
 Effective computer skills, including the use of Microsoft (MS) Word, MS Excel, Adobe Acrobat, etc.
 Capable of independently assessing sponsor needs and working with project team members in 
producing compliant deliverables
 Capable of independently learning new technologies
Management Role:
Directs through lower management levels and / or highly skilled specialist employees who exercise 
significant latitude and independent judgment. Often heads one or more departments or a large 
centralized staff function. In some instances may be responsible for a functional area (as determined by 
executive management) and not have subordinate supervisors or employees. May manage employees 
across multiple regions.
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.