The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Driven by a commitment to research, quality and service, PDI provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!
The Senior Regulatory Affairs Associate will support pre-market and post-market activities for Drugs and Medical Devices in the US and Canada. This position will be responsible for preparing clear and accurate Regulatory strategies for new products and changes to existing products. He/She will author regulatory submissions to the FDA (including INDs, NDAs and supplements) and will maintain drug and device site licenses for U.S and Canada. He/She will be responsible for reviewing ingredients, labeling, claims and technical documents for accuracy and regulatory compliance. Must have attention to detail, strong verbal and writing skills, and the ability to work independently.
Develop and execute Regulatory strategies with clear pathway to bring new products to market according to appropriate regulatory requirements.
Plan and author regulatory submissions including NDAs, Supplements, INDs, and Annual Reports to be filed with FDA, following eCTD requirements.
Review study reports and technical documents for regulatory submissions to ensure accuracy and regulatory compliance.
Collaborate with other functions (e.g. R&D, Procurement, Marketing, Quality) to gather information required for regulatory submissions.
Participate in Core Teams to support new product development projects and provide timely and accurate regulatory guidance. Review and approve ingredients and labeling materials for Drugs and Medical Devices.
Approve controlled documents, including product specifications, protocols and change controls.
Write new SOPs and Work Instructions and provide training to other colleagues.
Monitor new global regulatory requirements for Drugs and Medical Devices (U.S and Canada), perform impact assessment with clear actions required for compliance, and communicate to key stakeholders.
Interact with consultants to manage registrations in Canada and prepares submissions to Health Canada for medical devices and drugs.
Assess adverse events for medical devices and drugs and prepare documents for reporting, if necessary.
Help maintain Regulatory Intelligence database, including regulations, guidance and standards that apply to PDI products.
Provide support to Customer Service by answering inquiries and completing forms and surveys from PDI’s customers.
Prepares regulatory documents and presentations for internal meetings.
Meet key Regulatory Milestones for all Core Team projects, including new product launches, cost improvement, changes to existing products and market expansion.
Prepare clear and accurate Regulatory Strategies and author quality submissions to the FDA, in compliance with all regulatory requirements.
Provide clear and accurate regulatory guidance to Core Team members and other functions.
Ensure that PDI drug products and medical devices comply with all applicable regulatory requirements.
All product and site licenses are valid and accurate, new products are registered before launch and registrations for discontinued products are canceled.
Applicants must have pharmaceutical industry experience and in depth knowledge of drug regulations in the US. An understanding of Medical Device requirements is desired but not required.
Experience authoring IND and NDA submissions to the FDA is required (eCTD format is a plus). Experience with 510(k) submissions to the FDA is a plus.
The successful candidate will have 5-plus years of applicable experience in the Pharmaceutical industry for U.S (Canada is a plus), including regulatory submissions, labeling reviews, regulatory assessments and strategy, product and site registrations.
Applicants must have experience reviewing technical documents, pre-clinical and clinical data to support regulatory submissions for drug products.
A successful track record in coordinating and leading multiple projects and experience interacting with cross-functional teams is required.
The ability to interpret regulations and perform and communicate an impact assessment is required.
A working knowledge of Medical Device Quality System Regulations, Pharmaceutical cGMPs and ISO 13485 is a plus.
Experience reviewing raw materials for compliance with regulatory restrictions, such as FDA restricted chemicals, Canada Hotlist, CA PROP65, inventory lists (DSL, REACH) and other state regulations is a plus.
A minimum of a BA/BS degree in life sciences. RAPS Certification is a plus.
In depth knowledge of US Drug regulations and IND/NDA filing requirements is required.
Understanding of US Medical Device regulations is a plus.
Understanding of Health Canada Drug and Medical Device regulations is a plus.
Ability to prepare and implement Regulatory Strategies.
Ability to clearly communicate Regulatory requirements.
Able to follow directions and be accountable for work assigned.
Able to work independently, multi-task and prioritize workload.
Ability to work with cross-functional teams.
Must have strong analytical, verbal and writing skills.
PDI Healthcare offers evidence-based, market leading Interventional Care, Environment of Care and Patient Care solutions, all designed to help reduce preventable infections, control associated costs, and ultimately help save lives across the healthcare continuum of care.