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.
Support pre-market and post-market activities for Drugs and Medical Devices in the US and Canada. Will process site and product registrations, as well as the maintenance of regulatory compliance for approved products during the post-marketing phase. Will assist in preparing regulatory submissions, including IND, NDA, 510(k) and DIN, in compliance with FDA and Health Canada requirements. Responsible for reviewing product ingredients, labels and claims for accuracy and regulatory compliance. Must have strong verbal and writing skills, work independently and attention to detail.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
REGISTRATIONS & FILING
Author regulatory submissions including NDAs, Supplements, IND amendments, Annual Reports and 510(k)s to be filed with FDA (eCTD experience preferred).
Review test reports for regulatory submissions.
Review technical documents for accuracy and regulatory compliance.
Assist in preparing Health Canada submissions for medical devices and drugs.
Assist in creating technical dossiers for product registrations in other markets (e.g. EU).
Assist assessing and reporting adverse events for medical device and drugs.
Collaborate with other functions (e.g. R&D, Procurement, Marketing, Sales) to answer customer’s inquiries and surveys.
Attend cross-functional meetings to provide regulatory guidance and support to different projects.
Develop and execute Regulatory strategies to bring new products to market according to appropriate regulatory requirements.
Review and approve ingredients and labeling materials for Drugs and Medical Devices.
Assist in preparing regulatory documents and presentations for internal meetings.
Approve controlled documents, including product specifications, protocols and change controls.
Write new SOPs and WIs and provide training to other colleagues.
Monitor new global regulatory requirements for Drugs and Medical Devices.
Perform impact assessment of new regulatory requirements in the U.S and Canada and communicate to key stakeholders.
Help maintain Regulatory Intelligence database, regulations, guidance and standards that apply to PDI.
Hit key Regulatory Milestones for all Core Team projects, including new product launches, cost improvement, changes to existing products and market expansion.
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 in depth knowledge of drug regulations in the US, while an understanding of Medical Device requirements is highly desired.
Experience working with IND and NDA submissions 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 labeling reviews, regulatory assessments and product registrations.
Applicants must have experience reviewing technical documents, pre-clinical and clinical data to support regulatory submissions for drug products. Knowledge of Medical Device Quality System Regulations, GMP 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 successful track record in coordinating and leading multiple projects and experience interacting with multiple and diverse business units is required.
· 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 highly desired.
· Understanding of Health Canada Drug and Medical Device regulations is a plus.
· Must have a minimum 5 years of Regulatory experience in the pharmaceutical industry (Medical Device industry is a plus).
· Demonstrated experience with IND and NDA submissions in eCTD format.
· Experience with eCTD publishing applications highly desired.
· Experience preparing 510(k) submissions for devices is preferred.
· Experience preparing and submitting DIN/NPN and Medical Device License applications to Health Canada is a plus.
List key skills and abilities the associate should possess to be successful in this position (i.e. Ability to handle confidential information in a professional manner)
· Ability to write and approve new SOPs and Work Instructions.
· Able to follow directions and be accountable for work assigned.
· Able to work independently, multi-task and prioritize workload.
· Must have a team attitude.
· Must have strong analytical, verbal and writing skills.
· Proficient in Microsoft Office applications.
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About Professional Disposables International
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.