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 well as 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 liaison with other departments.

-Advanced computer skills including the use of Microsoft Word, Excel, PowerPoint, Adobe Acrobat, and the capability to learn new technologies. -Excellent organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities, and handle multiple projects. -Professional negotiation skills. -Capable of working independently and exercising independent judgment to assess sponsor regulatory needs, propose innovative regulatory strategies, work with project team members to produce compliant deliverables, and ensure audit readiness. -Advanced understanding of global/regional/national requirements and regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management. -Expert knowledge of ICH and other global regulatory guidelines, with in-depth expertise in regulatory 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 public relation functions. -Effective critical and strategic thinking skills. -Capable of developing, supervising, evaluating, and mentoring departmental personnel, as well as 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 complex projects in parallel and manage rapidly changing priorities. -Capable of independently learning new technologies and providing strategies for tools/systems improvement 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 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.