Our client is a leading provider of non-opioid pain management and regenerative health solutions. They are seeking a Regulatory Affairs Associate Director or Director who can develop and implement regulatory strategies for multiple projects. You will provide regulatory oversight and leadership for assigned programs in order to secure timely approval by regulatory agencies. With two marketed products, this company offers a passionate, small-company environment with the opportunity to wear many hats. Now is an exciting time to join this growing organization and help advance patient care.
- Develop and implement regulatory strategies for non-opioid pain management programs.
- Serve as Regulatory Affairs representative for assigned projects in development and approved products.
- Provide advice to cross-functional product development teams on regulatory issues as they arise with the pipeline products or marketed products throughout the entire life cycle of the drug.
- Responsible for establishing strategies for document authoring, contributing strategically and scientifically at the project and/or study team level, managing vendors and external writers with regard to document quality, and developing regulatory writing timelines, processes, and working standards.
- Provide regulatory input for product labeling, advertisement and promotion, and clinical projects.
- Develop submission plans and provides project management preparation of submission dossiers to US and international health agencies in the areas of new drug development and approved product support. This includes IND/CTA applications, BLA/NDA/MAA applications, annual reports, investigator brochures, clinical reports, and meeting requests/briefing packages, and others.
- If applicable and according to the individual’s experience, develop submission plans and provides project management preparation of submission dossiers for medical device development and approved product support. This includes IDE, PMA and 510k applications in the US, as well as their ex-US equivalents.
- Ensure that regulatory submissions are of high quality and submitted in a timely manner.
- Review regulatory filings for accuracy, completeness, and compliance with applicable regulatory requirements and internal procedures.
- Independently develop regulatory documents for regulatory submission such as eCTD module 2 summaries, health authority meeting briefing documents, and other regulatory documents as needed.
- Review and approve Study Protocols, Clinical Study Reports, Statistical Analysis Plans, ISS and product labeling.
- Ensure fulfillment of commitments made to various health agencies (e.g., IND/NDA/MAA pediatric and post-marketing commitments, and others).
- Manage vendors and external writers with regard to document quality; provide guidance to external writers on company standards and style and industry best practices for regulatory writing.
- Bachelor’s degree in a scientific field. Advanced degree, such as PharmD, PhD, MS preferred.
- Eight or more years of experience in Regulatory Affairs for biopharmaceutical programs. Biologics experience is a must.
- Demonstrated experience working directly with FDA and global Health Authorities (EMA, Health Canada, PMDA, etc)
- Strong knowledge of drug development and regulatory policy.
- Experience developing and leading regulatory strategies for INDs, NDAs, BLAs, and/or MAAs.
- Knowledge of clinical development, including responsibilities for successful management of development milestones and marketing authorization, meeting facilitation, and regulatory responses.
- Knowledge of regulations and specific experience in new medical device development is a plus.
- Demonstrated knowledge of global (US, EU/UK and ICH) regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues.
- Ability to manage multiple responsibilities with a high degree independence.
- Strong organizational skills, negotiating, and problem-solving skills.
- Excellent written and oral English communication skills.
- Proven ability to interact successfully with all levels of the organization.
- Proven time/project management skills.
This position will be onsite at the client’s office in New Jersey. Please note that this company will only consider local candidates and there is no relocation assistance.