Senior Director Regulatory Affairs Clinical Strategy
- Experience Level
We are working with a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Their in-depth knowledge of non-opioid pain management, coupled with their passion for advancing patient care, drives their commitment to providing solutions that address unmet medical needs and improve clinical results.
The Senior Director, Regulatory Affairs Clinical Strategy will be responsible for development and implementation of worldwide regulatory strategy leading to successful registration and life-cycle management of assigned projects. The incumbent will work with a high degree of independence; provide regulatory oversight and leadership for assigned products in order to optimize product labeling and time to approval by regulatory agencies; provide appropriate sense of urgency to cross-functional teams responsible for global programs; ensure effective communication and constructive working relationship with business partners and representatives of FDA and other global health authorities; coordinate the preparation, submission, and follow-up contact with regulatory agencies and/or external partner for all applications and submissions; be responsible for regulatory review for all submissions and associated documentation; be responsible for building and leading a strong clinical strategy team; and build strong cross-functional working relationships to ensure appropriate organizational support for clinical regulatory development strategies.
- Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple projects simultaneously.
- Provides 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.
- Provides leadership and guidance to direct reports in supporting and leading the cross-functional teams for pipeline programs and marketed products.
- Represents the company in direct communication with the FDA, including telephone calls and email; chair meeting between the company and FDA; prepares the company’s teams for meetings with FDA at any phase of drug development.
- Coordinates interactions with foreign agencies through external regulatory representatives to support their interactions and provide strategic direction across multiple regions simultaneously.
- Provides leadership in preparation of regulatory filings for submission to US and international regulatory agencies in the areas of new drug development marketing applications, and approved product support. This would include IND applications, meeting requests, post-marketing commitments, and annual reports.
- Establish strategies for document authoring, contributing strategically and scientifically at the project and/or study team level, directing Clinical Research Organizations (CROs) and external writers with regard to document quality, and developing medical writing timelines, processes, and working standards.
- Determines regulatory document authoring resource needs, proactively identifies issues and solutions, and sets timelines and processes for regulatory documents.
- Ensures key messages are clear and consistent within and across documents.
- Reviews and approves worldwide marketing applications, clinical study reports, investigator brochures before release from the company to external agencies and investigators.
- Conducts initial IND and Clinical Trial Applications (CTA) content review and approval to facilitate initial approval by agencies for conduct of clinical trials.
- Collaborates 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.
- Manages 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.
- Manages, leads, and mentors a subteam of regulatory strategists.
- Proactively identifies and addresses complex problems; proposes solutions, assists in developing solutions, and escalates any unresolved concerns to the senior leadership.
- Participates in regulatory due diligence activities for licensing/partnership candidate review.
- Leads cross-functional efforts to prepare for advisory committee meetings and may speak at the advisory committee.
- Masters or Doctoral degree in an applicable field of study.
- Minimum of 5 years of experience in pharmaceutical regulatory affairs or other relevant experience.
- Demonstrated knowledge of regulatory requirements with the ability to interpret and apply regulations to specific projects (IND, NDA, GCP, ICH and other regulatory guidance requirements).
- 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.
- Demonstrated public speaking skills.
- Proven time/project management skills.
- Proficiency in Microsoft Office including Word, Excel, and PowerPoint.
- This position requires approximately 10-15% travel with overnight stays.
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything we do.