Director, Regulatory Affairs FSP

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Discover Impactful Work:

Provides operational leadership for the department overseeing innovative solutions including regulatoryexpertise and client interface to provide strategic regulatory intelligence and guidance for productdevelopment from preclinical through registration and product optimization. Oversees projects andparticipates in strategic initiatives acts as lead subject matter expert. Acts as liaison with internal andexternal clients in the provision and marketing of regulatory services.

A day in the Life:

Manages staff which may include interviewing and selection job descriptionpreparation 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 the companys Equal Employment Opportunity policy
and Affirmative Action Plan. Assures department adherence to good ethical andregulatory 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 clients projects. Serves as the
executive contact for key clients for all issues including attendance at
regulatory authority meetings and other public relations functions which may
be held face-to-face (F2F) or virtually. Ensures quality performance for
key/managed projects.
Oversees 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 mannerand liaises with other departments to follow through on all aspects of contractmodification.

Collaborates with business development and senior management in pricing andsecuring new business by making presentations to clients developing andreviewing bid proposal texts and budgets and conducting contract negotiationthrough to closure with the client and BD. Actively engages in businessdevelopment activities looking to attract collaborative and stand-alone projects.
Pursues existing clients who have a need for services to win more business.
Contributes to development and implementation of global/regional
function/plans.
Ensures compliance with relevant organizational and department Standard
Operating Procedures (SOPs) and Work Instructions (WIs).
Develops strategy and leads the development and implementation of processesand procedures to increase productivity and accuracy within the team.

Keys to Success:

Education and Experience:

• Bachelors degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge skills and abilities to perform the job (comparable to12 years).
• 5 years of management responsibility
• Strong leadership skills

In some cases an equivalency consisting of a combination of appropriate education trainingand/or directly related experience will be considered sufficient for an individual to meet therequirements of the role.

Knowledge Skills Abilities

-Mastery of English language communication and negotiation skills both oral and written as wellas local language where applicable.
- Sharp attention to detail and quality with advanced editorial and proofreading skills.
- Accomplished interpersonal skills to work effectively in a team environment and act as a liaisonwith other departments.
-Advanced computer skills including the use of Microsoft Word Excel PowerPoint Adobe Acrobatand the capability to learn new technologies.

-Excellent organizational time management and planning skills to create and follow timelinesconduct long-range planning adapt to changing priorities and handle multiple projects.
-Professional negotiation skills.
-Capable of working independently and exercising independent judgment to assess sponsorregulatory needs propose innovative regulatory strategies work with project team members toproduce compliant deliverables and ensure audit readiness.
-Advanced understanding of global/regional/national requirements and regulatory affairsprocedures for clinical trial authorization licensing and lifecycle management.
-Expert knowledge of ICH and other global regulatory guidelines with in-depth expertise inregulatory specialty areas such as preclinical clinical CMC MDD publishing etc.

-Advanced understanding of medical terminology statistical concepts and guidelines.
-Sharp analytical investigative and problem-solving skills.
-Advanced understanding of budgeting and forecasting with the ability to interpret data.
-Recognized executive presence with consultation and presentation skills.
-Key representative of the company and clients at regulatory authority meetings and other publicrelation functions.
-Effective critical and strategic thinking skills.

-Capable of developing supervising evaluating and mentoring departmental personnel as wellas delegating tasks and facilitating the completion of assignments.
-Capable of contributing to global and regional functions implementation resourcing development and expansion.
-Capable of driving innovation in developing new ideas related to process improvements.
-Excellent judgment analytical decision-making and interpersonal skills to manage complexprojects in parallel and manage rapidly changing priorities.
-Capable of independently learning new technologies and providing strategies for tools/systemsimprovement to meet global regulatory requirements.
-Capable of identifying and assessing risks and impacts to core functions.

Physical Requirements / Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations frequent travels both domestic and international.
• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast simple repeated movementsof 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 laptopcomputer 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 tolisten 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 ofintense concentration.
• Performs a wide range of complex tasks as dictated by variable demands and changing conditionswith little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.