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Director, Regulatory Affairs FSP
Director, Regulatory Affairs FSPThermo Fisher Scientific • Morrisville, North Carolina, USA
Director, Regulatory Affairs FSP

Director, Regulatory Affairs FSP

Thermo Fisher Scientific • Morrisville, North Carolina, USA
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  • [job_card.full_time]
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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

This is a fully remote role.

We welcome applicants from all locations within the US.

Must be legally authorized to work in the United States withoutsponsorship.

Must be able to pass a comprehensive background check whichincludes a drug screening.

At Thermo Fisher Scientific youll 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.

This role will be within our FSP group. We have a functional service provider solution which is a unique partnership that allows our customers to leverage the experience of our staff while allowing you the employee to gain direct experience working onsite at a pharmaceutical / biopharmaceutical company all while maintaining full-time benefits.

Position Summary

The Director Clinical Regulatory Affairs serves as a senior regulatory leader responsible for shaping and executing the global clinical regulatory strategy across clients development portfolio. This role oversees end-to-end planning and delivery of global clinical submissions leads the creation and release of core regulatory dossiers drives country-level customization strategies and ensures high-quality responses to regulatory RFIs to support timely trial startup and advancement. The Director Clinical Regulatory Affairs partners closely with Clinical Operations Clinical Development Safety and CMC leadership and serves as a key point of contact for global regulatory agencies on clinical matters.

Key Responsibilities

Strategic Leadership & Regulatory Planning

  • Define and lead the companys global clinical regulatory strategy ensuring alignment across programs territories and development milestones.
  • Serve as the senior regulatory advisor to program teams helping shape clinical development plans scientific strategies and geographic expansion.
  • Stay abreast of the regulatory landscape and regulatory requirements. Anticipate regulatory challenges conduct strategic risk assessments and propose clear data-driven mitigation strategies.
  • Represent Regulatory Affairs leadership in governance forums providing decision-making support and regulatory insights to senior management.

Global Submission Strategy & Execution

  • Oversee the planning authorship review and delivery of all major clinical regulatory submissions including :

    • New Drug Application (NDA)

  • IND / CTA filings and amendments
  • Health authority pre-submission and post-submission packages
  • DSURs Annual Reports SUSAR submissions
  • Protocols IBs and related clinical documentation
  • Lead cross-functional submission teams with CROs ensuring clarity of roles timelines and quality expectations.
  • Establish and continuously optimize submission processes tools templates and governance standards.

    • Core Dossier Management & Country Customization

  • Direct the development release and lifecycle management of global core clinical dossiers ensuring scientific rigor regulatory compliance and internal alignment.
  • Drive strategies for efficient global rollout including harmonization across regions and scalable dossier architecture.
  • Provide executive-level guidance to regional teams on country-specific customization ensuring adherence to local regulations formats language requirements and health authority expectations.
  • Approve localized submissions for strategic consistency and regulatory integrity.

    • Regulatory RFIs & Agency Interactions

  • Oversee the development of robust scientifically sound and timely Requests for Information (RFI) responses ensuring alignment with overall regulatory and clinical strategy.
  • Lead preparation for and participation in key regulatory interactions (FDA EMA MHRA PMDA and other agencies).

    • Clinical Operations Partnership & Trial Execution

  • Partner with Clinical Operations leadership to ensure regulatory considerations are fully integrated into trial startup conduct and closeout.
  • Guide regional feasibility and startup planning from a regulatory perspective including country prioritization and risk management.
  • Oversee vendor and CRO performance related to regulatory responsibilities.
  • Ensure organization-wide inspection readiness and provide senior oversight during audits and regulatory inspections.

    • Knowledge Skills Abilities

    Education and Experience :

  • Bachelors degree in life sciences or related field; advanced degree strongly preferred
  • 12 years of regulatory affairs experience in biotech / pharma including 5 years of substantial leadership experience supporting global clinical programs.
  • Demonstrated success leading global IND / CTA submissions dossier management and regulatory interactions.
  • Expertise in crafting high-quality RFI responses and managing complex regulatory communications.
  • Deep knowledge of ICH GCP global clinical trial regulations and regional requirements (FDA EMA MHRA NMPA PMDA etc.).
  • Proven experience influencing cross-functional leaders and driving alignment on regulatory strategy.
  • Outstanding communication leadership and organizational skills.

    • In some cases an equivalency consisting of a combination of appropriate education trainingand / or directly related experience will be considered sufficient for an individual to meet therequirements of the role.

    Preferred

  • Experience with biologics gene therapies cell therapies or other advanced modalities.
  • Prior responsibility for global rollout of core clinical dossiers or large-scale clinical submission programs.
  • RAC certification or equivalent credential.
  • Experience in fast-paced or emerging biotech environments.

    • 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 movementsof 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 laptopcomputer 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 tolisten 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 ofintense concentration.
  • Performs a wide range of complex tasks as dictated by variable demands and changing conditionswith little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
  • Regular and consistent attendance.

    • We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!

    Required Experience :

    Director

    Key Skills

    Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

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