Job Information
Battelle Memorial Institute Regulatory Affairs Director - Remote US in Remote, Massachusetts
Battelle delivers when others can’t. We conduct research and development, manage national laboratories, design and manufacture products and deliver critical services for our clients—whether they are a multi-national corporation, a small start-up or a government agency.
We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply.
Job Summary
At Battelle Health, our team of expert problem-solvers are as passionate as you are about finding solutions to the world’s most pressing health challenges. Combining decades of experience with the tools and resources to push the limits of what’s possible, we turn research, theories and ideas into practical solutions that impact lives. Health is one thing that connects us all, because our need to not only survive, but to thrive is something we all have in common. Healthcare innovation is at the core of what we do.
Join Battelle as the Regulatory Affairs Director where you will lead and drive the organization’s regulatory affairs strategy for our Health Business Unit. This position will lead all regulatory activities within the business working closely with clients and internal departments to:
Champion regulatory compliance against evolving regulatory requirements.
Drive client regulatory strategy development.
Prepare documents for submission to regulatory authorities.
Manage required regulatory reporting.
Serve as the primary point of contact with regulatory agencies.
As a member of Battelle’s Performance Excellence organization, you will report to the Vice President of Performance Excellence and work with Legal, Quality, and Product Development and Testing teams throughout clinical development and product lifecycle for assigned projects. This position supports operations in Columbus, OH; Boston, MA but may be remote.
Major Responsibilities
Direct all regulatory matters and lead strategy to ensure the Health Business Unit complies with applicable regulations. Lead and direct proposal and project teams on regulatory matters.
Maintain and share knowledge of current industry trends in products and services, regulatory environment, noncompliance trends, and emerging industry best practice by continually reviewing relevant resources for new information.
Research and develop internal regulatory strategies, evaluate risk and plan contingencies for proposed regulatory strategies, and recommend regulatory pathway(s) for investigational, new, or modified products and services.
Serve as primary liaison between regulatory bodies and the Health Business Unit and other key stakeholders including senior management.
Interface and coordinate with the regulatory agencies (i.e., FDA) on submissions, approvals, external audits, and other topics.
Lead preparation and management of timely regulatory submissions, including INDs, NDAs, Annual Reports, and briefing documents.
Coordinate regulatory agency meeting activities, including preparing meeting materials, and meeting attendance.
Prepares and submits all other applications and reports to applicable regulatory agencies.
Responds to requests for information from regulatory bodies.
Maintains and fosters effective agency relationships.
Select, lead, and direct 3rd party consultant performance and workload to support regulatory operations.
Manage the development and maintenance of regulatory files and databases.
Author and develop Operational SOPs, work instructions, and forms, develop training models, reference materials, and presentations to ensure target staff obtain and sustain proficiencies sufficient to comply with applicable US regulations and required submissions.
Support quality teams to ready and host customer and registrar audits and agency inspections. Consult and support in related planning and response.
The Following Qualifications are Required
Requires bachelor’s degree with at least 10 years of related work experience, science degree in regulatory affairs or health sciences preferred or equivalent level of education and work experience.
Strong writing, speaking, and interpersonal skills; adept at in-person and remote communications.
Strong working knowledge of current FDA biologic, device, and drug regulations, including combination products. Demonstrated regulatory strategic planning including nonclinical and clinical phases of development through approvals.
Demonstrated ability to engage directly with the FDA, responsive to submissions, planned and unannounced inspections, and findings.
Ability to obtain and maintain a U.S. government security clearance (U.S. citizenship required).
Ability to manage multiple projects while thinking critically and creatively to provide product-focused regulatory pathway/strategy recommendations.
Demonstrated success in preparing and submitting applications to the FDA and/or other regulatory agencies.
Demonstrated success in strategic thinking, collaboration, and analytical problem solving.
A curious mindset.
The Following Qualifications are Preferred
Regulatory Affairs Certification (RAC) preferred.
Diplomate American Board of Toxicology.
Experience with product and study development under the Animal Rule.
Experience with both commercial and government clients.
Experience with medical countermeasure development.
Additional Information
A combination of education and experience may be considered for this role.
This position can be remote, but applicants must be based in the U.S.
Assume up to 25% travel to Battelle’s place(s) of business and/or to meetings with regulatory agencies may be required.
Benefits: Live an Extraordinary Life
We care about your well-being, not just on the job. Battelle offers comprehensive and competitive benefits to help you live your best life.
Balance life through a compressed work schedule : Most of our team follows a flexible, compressed work schedule that allows for every other Friday off—giving you a dedicated day to accomplish things in your personal life without using vacation time.
Take time to recharge : You get paid time off to support work-life balance and keep motivated.
Prioritize wellness : Stay healthy with medical, dental, and vision coverage with wellness incentives and benefits plus a variety of optional supplemental benefits.
Better together : Coverage for partners, gender-affirming care and health support, and family formation support.
Build your financial future : Build financial stability with an industry-leading 401(k) retirement savings plan. For most employees, we put in 5 percent whether you contribute or not, and match your contributions on top of that.
Advance your education : Tuition assistance is available to pursue higher education.
Flexible work arrangements : You have options for where you work and when you work.
A Work Environment Where You Succeed
For brilliant minds in science, technology, engineering and business operations, Battelle is the place to do the greatest good by solving humanity’s most pressing challenges and creating a safer, healthier and more secure world.
You will have the opportunity to thrive in a culture that inspires you to:
Apply your talent to challenging and meaningful projects
Receive select funding to pursue ideas in scientific and technological discovery
Collaborate with world-class experts in an inclusive environment
Nurture and develop the next generation of scientific leaders
Give back to and improve our communities
Vaccinations & Safety Protocols
Battelle may require employees, based on job duties, work location, and/or its clients’ requirements to follow certain safety protocols and to be vaccinated against a variety of viruses, bacteria, and diseases as a condition of employment and continued employment and to provide documentation that they are fully vaccinated. If applicable, Battelle will provide reasonable accommodations based on a qualified disability or medical condition through the Americans with Disabilities Act or the Rehabilitation Act or for a sincerely held religious belief under Title VII of the Civil Rights Act of 1964 (and related state laws).
Battelle is an equal opportunity employer. We provide employment and opportunities for advancement, compensation, training, and growth according to individual merit, without regard to race, color, religion, sex (including pregnancy), national origin, sexual orientation, gender identity or expression, marital status, age, genetic information, disability, veteran-status veteran or military status, or any other characteristic protected under applicable Federal, state, or local law. Our goal is for each staff member to have the opportunity to grow to the limits of their abilities and to achieve personal and organizational objectives. We will support positive programs for equal treatment of all staff and full utilization of all qualified employees at all levels within Battelle.
The above statements are intended to describe the nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, activities and skills required of staff members. No statement herein is intended to imply any authorities to commit Battelle unless special written permission is granted by Battelle's Legal Department.
For more information about our other openings, please visit www.battelle.org/careers