Our client is a leading provider of non-opioid pain management and regenerative health solutions. They are seeking a Regulatory Affairs Clinical Strategy Director or Sr. Director who can develop and implement worldwide regulatory strategies leading to successful registration and life-cycle management of assigned 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 worldwide regulatory strategies for non-opioid pain management programs.
- Provide expert 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.
- Provide regulatory leadership and guidance to direct reports in supporting and leading the cross-functional teams for pipeline programs and marketed products.
- Lead direct communication with the FDA, including telephone calls and email. Prepare for and lead meetings with FDA at any phase of drug development.
- Coordinate interactions with foreign agencies through external regulatory representatives and provide strategic direction across multiple regions simultaneously.
- Provide leadership in preparation of regulatory filings for submission to US and international regulatory agencies for new drug development marketing applications and approved product support.
- Lead the assembly of regulatory packages for IND, CTA, BLA, NDA, or MAA submissions for new product development.
- If applicable and according to the individual’s experience, develop submission plans and provide project management for medical device development and approved product support. This includes IDEs, PMAs, and 510(k) applications in the US, as well as their ex-US equivalents.
- Conduct initial IND and CTA content review and approval to facilitate initial approval by agencies for conduct of clinical trials. Review and approve worldwide marketing applications, clinical study reports, and investigator brochures.
- Collaborate with regulatory publishing team to ensure regulatory submissions are of high quality and submitted in a timely manner; review submissions for accuracy, completeness, and compliance with applicable regulatory requirements and procedures.
- Manage regulatory projects including overall strategy, resources, costs, time and vendors, if appropriate and ensure that project work proceeds according to agreed deadlines and maintains status records.
- Proactively identify and addresses complex problems; propose solutions, assist in developing solutions, and escalate any unresolved concerns to the senior leadership.
- Participate in regulatory due diligence activities for licensing/partnership candidate review.
- May have Supervisory responsibility for 1-2 regulatory strategists.
- Bachelor’s degree in a scientific field. Advanced degree, such as PharmD, PhD, MS preferred.
- Ten years of industry experience with eight or more years of experience in Regulatory Affairs for biopharmaceuticals. 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.