Director Regulatory Affairs at NSF International
Germantown, MD 20874
About the Job
The Director of Regulatory Strategy is responsible for shaping and executing regulatory strategies for clinical development programs and regulatory submissions across multiple therapeutic areas
This leadership role requires deep knowledge of global regulatory environments, strong cross-functional collaboration, and a focus on providing expert guidance to internal teams and external clients
The role plays a critical role in the planning and delivery of regulatory services, from preclinical development through marketing authorization.The Director of Regulatory Strategy will lead and oversee the implementation and optimization of the Docshop AI-driven regulatory document review, processing, and publishing process
This role requires expertise in regulatory submissions, document management, and the ability to leverage advanced AI technologies to streamline regulatory workflows
The Director will be responsible for developing strategies to integrate AI capabilities into the document review process, ensuring compliance with regulatory requirements, enhancing efficiency, and reducing submission timelines
Key responsibilities include guiding the automation of document formatting, ensuring the accuracy of regulatory content, managing regulatory submissions, and collaborating with cross-functional teams to maintain high-quality standards
This position is ideal for a proactive leader who can navigate the evolving regulatory landscape and drive innovative AI solutions for regulatory document management.The Director of Regulatory Strategy will play a pivotal role in collaborating with Regulatory leadership from the NSF Life Sciences Leadership Team across Pharma/Biotech and Medical Devices business units
This position is responsible for driving the development and execution of comprehensive regulatory strategies that align with the broader business objectives of these units
The Director will work closely with cross-functional regulatory leaders to develop, refine, and implement strategic business plans that support product development, regulatory submissions, and market access strategies
This role requires a deep understanding of the regulatory landscape, the ability to anticipate challenges, and the expertise to integrate insights from multiple business units to create unified strategies that advance the company’s objectives in the highly regulated life sciences sector
The ideal candidate will possess strong leadership skills, a collaborative mindset, and a proven track record in regulatory strategy development within Pharma/Biotech and Medical Devices industries.
At NSF, our mission is to improve human and planet health by enabling safe food, clean water, and life-enhancing health technologies and products for millions of people around the world
We’re a global leader in standards development, testing, auditing, certification, and knowledge-based solutions for the food, nutrition, water, and life sciences industries
We’re passionate about our work because together, we have a broad impact on our world.
Our growing team of more than 3,000 team members provide services across all continents through our global offices and state-of-the-art laboratories, at our client sites, and from home offices
We’re growing fast and expanding into new areas, and that’s where you come in.
Come join a team that makes a difference in the world
More information about NSF can be found at nsf.org.
One of our core values is We Are One NSF
This means that while we’re one team, we embrace the cultural, ethnic, language and demographic diversity that reflects the societies in which we live and work
NSF is an equal opportunity employer
All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability.
NSF works with pharmaceutical, dietary/nutritional supplements and personal care products, medical devices and in vitro diagnostic companies, large and small, to provide highly customized end-to-end services throughout the product lifecycle, from clinical trials to post-market surveillance
We are a global provider of clinical trials, training, consultancy, certification and auditing services to the health sciences industry
We have an outstanding international reputation in quality management and regulatory compliance
We provide comprehensive solutions for the health sciences industry from experts you can trust
Our team includes former FDA, EU and MHRA regulators as well as industry experts
We combine regulatory knowledge with industry best practices to provide our clients with tailored quality, compliance and regulatory servicesAdvanced degree in life sciences (e.g., PhD, PharmD, MS) or equivalent experience in a regulatory or scientific discipline.Minimum of 8-10 years of regulatory affairs experience, preferably in a CRO, pharmaceutical, or biotechnology environment.Proven track record of success in developing and executing regulatory strategies for global clinical trials and marketing applications.Strong knowledge of FDA, EMA, ICH, and other international regulatory guidelines and requirements.Excellent leadership, communication, and problem-solving skills, with the ability to navigate complex regulatory challenges.Experience interacting with regulatory agencies and leading regulatory submissions.Ability to work effectively in a fast-paced, matrixed environment and manage multiple priorities and projects simultaneously.Strong attention to detail, with a commitment to high-quality standards in regulatory submissions and client deliverables.Notice to Agency and Search Firm Representatives: Please note that NSF is not accepting unsolicited resumes from agencies/search firms for this role
Resumes submitted to an NSF Employee by a third-party agency without a valid written & signed search agreement, will become sole property of NSF
No fee will be paid if a candidate is hired as a result of an unsolicited agency or search firm referral
Thank you.Develop, lead, and oversee the implementation and optimization of the AI-driven regulatory document review, processing, and publishing process (DocShop)Develop and lead innovative regulatory strategies to support the global development, approval, and lifecycle management of clinical programs, ensuring alignment with client goals and regulatory requirements.Serve as the primary regulatory expert, advising clients on regulatory pathways, submission strategies, and risk mitigation for drug, biologic, and medical device development.Oversee the preparation and submission of regulatory documents, including INDs, NDAs, BLAs, CTAs, MAAs, and other global regulatory filings.Lead regulatory interactions with health authorities (e.g., FDA, EMA, PMDA), including pre-submission meetings, scientific advice, and advisory committee meetings.Collaborate with internal project teams (clinical, safety, data management, etc.) to ensure regulatory compliance and strategic alignment across all development activities.Monitor and interpret evolving regulatory guidelines and industry trends, proactively updating clients and internal teams on changes that may impact clinical development and submission strategies.Support business development efforts by providing regulatory insights during client meetings, proposal development, and bid defenses.Mentor and guide a team of regulatory professionals, fostering a culture of continuous learning and regulatory excellence.Manage regulatory timelines, deliverables, and resources to ensure on-time completion of project milestones and submissions.Develop and update SOPs and training procedures.Internal and external auditing for GCP or GMP complianceOther duties as assigned.#LI-BH1Full timePosting Date: 2024-09-25
This leadership role requires deep knowledge of global regulatory environments, strong cross-functional collaboration, and a focus on providing expert guidance to internal teams and external clients
The role plays a critical role in the planning and delivery of regulatory services, from preclinical development through marketing authorization.The Director of Regulatory Strategy will lead and oversee the implementation and optimization of the Docshop AI-driven regulatory document review, processing, and publishing process
This role requires expertise in regulatory submissions, document management, and the ability to leverage advanced AI technologies to streamline regulatory workflows
The Director will be responsible for developing strategies to integrate AI capabilities into the document review process, ensuring compliance with regulatory requirements, enhancing efficiency, and reducing submission timelines
Key responsibilities include guiding the automation of document formatting, ensuring the accuracy of regulatory content, managing regulatory submissions, and collaborating with cross-functional teams to maintain high-quality standards
This position is ideal for a proactive leader who can navigate the evolving regulatory landscape and drive innovative AI solutions for regulatory document management.The Director of Regulatory Strategy will play a pivotal role in collaborating with Regulatory leadership from the NSF Life Sciences Leadership Team across Pharma/Biotech and Medical Devices business units
This position is responsible for driving the development and execution of comprehensive regulatory strategies that align with the broader business objectives of these units
The Director will work closely with cross-functional regulatory leaders to develop, refine, and implement strategic business plans that support product development, regulatory submissions, and market access strategies
This role requires a deep understanding of the regulatory landscape, the ability to anticipate challenges, and the expertise to integrate insights from multiple business units to create unified strategies that advance the company’s objectives in the highly regulated life sciences sector
The ideal candidate will possess strong leadership skills, a collaborative mindset, and a proven track record in regulatory strategy development within Pharma/Biotech and Medical Devices industries.
At NSF, our mission is to improve human and planet health by enabling safe food, clean water, and life-enhancing health technologies and products for millions of people around the world
We’re a global leader in standards development, testing, auditing, certification, and knowledge-based solutions for the food, nutrition, water, and life sciences industries
We’re passionate about our work because together, we have a broad impact on our world.
Our growing team of more than 3,000 team members provide services across all continents through our global offices and state-of-the-art laboratories, at our client sites, and from home offices
We’re growing fast and expanding into new areas, and that’s where you come in.
Come join a team that makes a difference in the world
More information about NSF can be found at nsf.org.
One of our core values is We Are One NSF
This means that while we’re one team, we embrace the cultural, ethnic, language and demographic diversity that reflects the societies in which we live and work
NSF is an equal opportunity employer
All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability.
NSF works with pharmaceutical, dietary/nutritional supplements and personal care products, medical devices and in vitro diagnostic companies, large and small, to provide highly customized end-to-end services throughout the product lifecycle, from clinical trials to post-market surveillance
We are a global provider of clinical trials, training, consultancy, certification and auditing services to the health sciences industry
We have an outstanding international reputation in quality management and regulatory compliance
We provide comprehensive solutions for the health sciences industry from experts you can trust
Our team includes former FDA, EU and MHRA regulators as well as industry experts
We combine regulatory knowledge with industry best practices to provide our clients with tailored quality, compliance and regulatory servicesAdvanced degree in life sciences (e.g., PhD, PharmD, MS) or equivalent experience in a regulatory or scientific discipline.Minimum of 8-10 years of regulatory affairs experience, preferably in a CRO, pharmaceutical, or biotechnology environment.Proven track record of success in developing and executing regulatory strategies for global clinical trials and marketing applications.Strong knowledge of FDA, EMA, ICH, and other international regulatory guidelines and requirements.Excellent leadership, communication, and problem-solving skills, with the ability to navigate complex regulatory challenges.Experience interacting with regulatory agencies and leading regulatory submissions.Ability to work effectively in a fast-paced, matrixed environment and manage multiple priorities and projects simultaneously.Strong attention to detail, with a commitment to high-quality standards in regulatory submissions and client deliverables.Notice to Agency and Search Firm Representatives: Please note that NSF is not accepting unsolicited resumes from agencies/search firms for this role
Resumes submitted to an NSF Employee by a third-party agency without a valid written & signed search agreement, will become sole property of NSF
No fee will be paid if a candidate is hired as a result of an unsolicited agency or search firm referral
Thank you.Develop, lead, and oversee the implementation and optimization of the AI-driven regulatory document review, processing, and publishing process (DocShop)Develop and lead innovative regulatory strategies to support the global development, approval, and lifecycle management of clinical programs, ensuring alignment with client goals and regulatory requirements.Serve as the primary regulatory expert, advising clients on regulatory pathways, submission strategies, and risk mitigation for drug, biologic, and medical device development.Oversee the preparation and submission of regulatory documents, including INDs, NDAs, BLAs, CTAs, MAAs, and other global regulatory filings.Lead regulatory interactions with health authorities (e.g., FDA, EMA, PMDA), including pre-submission meetings, scientific advice, and advisory committee meetings.Collaborate with internal project teams (clinical, safety, data management, etc.) to ensure regulatory compliance and strategic alignment across all development activities.Monitor and interpret evolving regulatory guidelines and industry trends, proactively updating clients and internal teams on changes that may impact clinical development and submission strategies.Support business development efforts by providing regulatory insights during client meetings, proposal development, and bid defenses.Mentor and guide a team of regulatory professionals, fostering a culture of continuous learning and regulatory excellence.Manage regulatory timelines, deliverables, and resources to ensure on-time completion of project milestones and submissions.Develop and update SOPs and training procedures.Internal and external auditing for GCP or GMP complianceOther duties as assigned.#LI-BH1Full timePosting Date: 2024-09-25
