Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Manager/Sr. Manager Regulatory Affairs, Clinical FSP Dedicated

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 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:

We are seeking a Regulatory/Senior Regulatory Affairs Manager in our FSP, Regulatory Team.

This role will be hired at Manager/Senior Manager level (please note: level hired is dependent on experience)

This role is for the North America region; EAST COAST strongly preferred and is remote based.

Summarized Purpose:

We are seeking a Regulatory/Senior Regulatory Manager to support our FSP, Clinical Research Team. This role is in need of a candidate who is able to initiate 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.

Essential Functions and Other Job Information:

Works with global regulatory lead(s), regulatory strategists, Global Regulatory Sub-Teams and project teams regarding the development and execution of regulatory strategy through the product development lifecycle.Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients; manages the coordination of and ensures quality performance for key client projects. Manages project budgeting/ forecasting. Leads and participates in project meetings.Manages the finalization and review of regulatory documents and submissions. 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 modifications.Collaborates with business development in pricing and securing new business by making presentations to clients and develops proposal texts and budgets in collaboration with other departments.Provides staff with up-to-date legislation and guidance as it becomes available. Ensures compliance with relevant organizational and department SOPs and WPDs.

Creates and leads the development and implementation of processes and procedures to increase productivity and accuracy within the team. Participates in developing and implementing systems and tools to continually improve efficiency of all activities supporting and facilitating process improvements, reduction in cycle times, submission activities, metrics and other key performance indicators.

Policy & Strategy:

Interprets and administers policies, processes, and procedures that may affect sections and subordinate work units.Acts as advisor to subordinate(s) to meet schedules and / or resolve technical problems.Requires full knowledge of own area of functional responsibility.

Liaison:

Interacts frequently with internal personnel and outside representatives at various levels.Participates and may present at meetings with internal and external representatives. Interaction typically concerns resolution of operational and scheduling issues concerning projects and / or contractual clarifications.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).Experience in Infectious Diseases and/or Biologicals highly is preferredSolid understanding of current US and EU regulationsExperience with CTD format and content of regulatory filingsExperience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.

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 and Abilities:

Strong English language communication and negotiation skills, as well as local language where applicable, both oral and written In-depth understanding of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing and lifecycle managementBroad understanding of ICH and other global regulatory guidelinesIn-depth knowledge of at least one of the regulatory specialty areas: preclinical, clinical, CMC, publishing, etc.Exceptional written and oral communication in English and Spanish.Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance--preferably from at least both US and EUDemonstrate strong organizational skills, including the ability to prioritize workload.Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.Experience in authoring regulatory documentsAdvanced understanding of budgeting and forecasting with the ability to interpret data with attention to detail and analytical and investigative skillsCapable of delegating tasks and facilitating the completion of assignmentsCapable of driving innovation in developing new ideas related to process improvementsAdvanced organizational, judgment, analytical, decision-making and interpersonal skills to manage complex projects in parallel and manage rapidly changing prioritiesEffective computer skills, including the use of Microsoft (MS) Word, MS Excel, Adobe Acrobat, etc.Capable of independently assessing sponsor needs and working with project team members in producing compliant deliverablesCapable of independently learning new technologies

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:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary for typical working hours.Ability to use and learn standard office equipment and technology with proficiency.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel.  (Recruiter will provide more details.) 

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.