FSP Sr Director Regulatory Affairs

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:

The Senior Director, Regulatory Affairs Functional Lead, FSP, provides strategic direction, leadership and management to the FSP Regulatory Affairs business segment

• Accountable 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 execution

• Partners 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 clients

• Provides 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 partnerships

• Work 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’ 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’, company and regulatory requirements

• Lead, 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 team  

Education and Experience Required:

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification

• Previous 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 area

• Experience managing direct reports across multiple geographic regions is preferred

• Demonstrated track record of success in leading and developing matrixed teams to YoY positive functional and organizational deliverables

• Proven experience developing and managing the budgets and resources of a segment of the Regulatory affairs business

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

• Excellent understanding of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing and life cycle management

• Superior  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 deliverables

• Strategic Leader with proven track record of developing and growing teams within the regulatory affairs space

• Ability to strategically support a business through rapid growth and/or change

• Strong commercial awareness, ability to assess revenue, margins, cost efficiencies and effectiveness

• Excellent decision-making skills to allow for management of complex projects in parallel with rapidly changing priorities in the regulatory space

• Outstanding analytical skills to support work on highly complex problems where analysis of situations or data requires evaluation of intangible variables

• Financial acumen, knowledge of budgeting, forecasting and resource management

• Excellent communication organizational and interpersonal skills

• Ability to function as a relationship builder who is able to work effectively in matrix organizations

Our 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! http://jobs.thermofisher.com

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.

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