Director, Regulatory Affairs - FSP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll 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 regulatory expertise and client interface to provide strategic regulatory intelligence and guidance for product development from preclinical through registration and product optimization. Oversees projects and participates in strategic initiatives, acts as lead subject matter expert. Acts as liaison with internal and external clients in the provision and marketing of regulatory services.

A day in the Life:

• 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 the company’s 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 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 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. Actively engages in business development 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 processes and procedures to increase productivity and accuracy within the team. 

Keys to Success:

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 12+ years). 
• 5+ years of management responsibility 
• Strong 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, Abilities

-Mastery of English language, communication and negotiation skills, both oral and written, as