Job Description

At Thermo Fisher Scientific, you\xe2\x80\x99ll 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 \xe2\x80\x93 now and in the future.Discover Impactful Work:The Senior Director, Regulatory Affairs Functional Lead, FSP, provides strategic direction, leadership and management to the FSP Regulatory Affairs business segmentAccountable for the Regulatory Affairs book of business as well as the growth of Regulatory Affairs FSP service offerings with critical focus on maximizing revenue, minimizing operating margins, while ensuring quality and exceeding client satisfaction by on time delivery and executionPartners with colleagues at the enterprise level, alliance management and business development and with FSP leadership to build and deliver creative and customized solutions for FSP clientsProvides advice and strategic guidance to team ensuring all aspects of regulatory activities comply with the sponsor, company and regulatory requirements.Essential Functions:Develops and drives the specific and overall Regulatory Affairs FSP strategy to ensure optimum performance and achievement of annual plans and targets for their FSP partnershipsWork effectively across multiple divisions including FSP leadership, Business Development Strategic Proposal Development, Talent Acquisition, Project Delivery and Bids/Contracts to support the Regulatory Affairs proposal process including client presentations.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 specific strategy, technical expertise and coordination oversight for clients\xe2\x80\x99 projects.Serves as executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public functions. Ensures quality performance for key/managed projects.Oversees and ensures all aspects of publishing and submission activities are conducted in accordance with sponsor companies\xe2\x80\x99, company and regulatory requirementsLead, develop and provide coaching to the FSP Regulatory Affairs team in cooperation with FSP Business segment leadership team and facilitates career development across the Regulatory Affairs teamEducation and Experience Required:Bachelor\'s degree or equivalent and relevant formal academic/vocational qualificationPrevious experience that provides the individual with the required knowledge, skills and abilities to perform the job, including several years of specific experience in a regulatory affairs function and speciality area (preclinical, clinical, CMC, publishing, etc)A demonstrated track record of success in leading, developing and growing a team of direct reports in the last 3 years and in leading and developing professional staff in a regulatory affairs focused environment or speciality areaExperience managing direct reports across multiple geographic regions is preferredDemonstrated track record of success in leading and developing matrixed teams to YoY positive functional and organizational deliverablesProven experience developing and managing the budgets and resources of a segment of the Regulatory affairs businessIn 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, AbilitiesExcellent understanding of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing and life cycle managementSuperior understanding of ICH and other global regulatory guidelines; advanced knowledge of at least one of the regulatory speciality areas; preclinical, clinical, CMC, publishing, etc.Highly capable of independently assessing Sponsor and FSP business needs, working with project team members in producing compliant deliverablesStrategic Leader with proven track record of developing and growing teams within the regulatory affairs spaceAbility to strategically support a business through rapid growth and/or changeStrong commercial awareness, ability to assess revenue, margins, cost efficiencies and effectivenessExcellent decision-making skills to allow for management of complex projects in parallel with rapidly changing priorities in the regulatory spaceOutstanding analytical skills to support work on highly complex problems where analysis of situations or data requires evaluation of intangible variablesFinancial acumen, knowledge of budgeting, forecasting and resource managementExcellent communication organizational and interpersonal skillsAbility to function as a relationship builder who is able to work effectively in matrix organizationsOur 4i Values:Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today!Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Thermo Fisher Scientific