Director, Regulatory Affairs FSP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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

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 :

Required Experience :

Director

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1