Job Title: Vice President, Global Regulatory Affairs
Reports To: Chief Medical Officer
Department: R&D
People Manager: Yes
FLSA Status: Exempt
Location: San Diego, CA
Summary
The Vice President of Global Regulatory Affairs will be responsible for leading the creation, evaluation, and recommendation of regulatory strategies and tactics to support the achievement of clinical program goals. Working with the cross-functional development team, they will lead all Health Authority meetings associated with the program, hold accountability for the program’s global regulatory plan and its execution, identify and assess regulatory risks associated with planned clinical development activities, and provide technical advice and counsel. This is a critical leadership role within the company and has significant influence on the achievement of corporate and program objectives and key results.
Responsibilities
- Lead the global regulatory strategy for the assigned product(s), accountability for ensuring that plans meet global regulatory requirements
- Leader Health Authority meeting planning, preparation, and conduct; accountable for delivery of optimal meeting outcomes
- Proactively identify and assess regulatory risks associated with planned clinical development activities
- Develop and provide oversight of submission content for global dossiers, including INDs and CTAs outside the US
- Review and approve all submission documents, including clinical study protocols and reports, statistical analysis plans, investigator brochures, development safety update reports, and other documents as needed
- Support strategy for providing submission of CMC and non-clinical information
- Act as the independent subject matter expert in giving guidance to project teams, departments, and management, while considering companywide implications
- Contribute to the development of target product profile and draft labeling
- Lead marketing application submission team(s)
Minimum Requirements
- Bachelor’s degree required, with an advanced degree in science (Ph.D., MD, JD, PharmD) strongly preferred
- 15+ years of industry experience with a minimum of 10+ years in progressive regulatory roles
- Experience and expertise in developing regulatory strategies leading to significant clinical development progress
- Experience and expertise in working with neurological and/or rare and orphan diseases are preferred
- Demonstrated success in working in a matrix team and collaborating cross-functionally with clinical development, clinical operations, commercial, technical operations, pharm/tox, and medical affairs.
- Significant experience w/US FDA regulations; strong understanding of Global Health Authority policies, laws, regulations, and guidelines as they apply to global drug development and approvals
- Significant knowledge of the drug development process (early stage through commercialization)
- Demonstrated ability to coordinate global activities, drive quality decision-making, organize/prioritize tasks, negotiate with and influence others, and facilitate issue resolution and conflict management
- Demonstrated ability to prepare for launch readiness / ensuring launch readiness
- Effective communication skills that allow for teamwork, collaboration, and open dialogue cross-functionally (verbal/written/email/presentation) is required. The need to speak with ease, confidence, and ability to come well-prepared and solution-focused with all levels of the leadership team.
- Ability to communicate regulatory strategy to key stakeholders at all levels of the organization is vital to the success of the role.
- Significant experience with identification and management of external resources and consultants
- Ability to travel up to 10% (US and International)
Pay Transparency
The expected salary for candidates who work in La, Jolla, CA is $300-350k. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we believe benefits are an important part of our employees’ overall compensation and well-being. We are pleased to offer a comprehensive array of valuable benefits to protect the health of our employees, their families and their way of life.
Our benefits currently include:
- Hybrid work schedule
- Competitive compensation package including bonus opportunities and stock options
- Medical, Dental & Vision Plans
- 401(k) Plan, including company match with immediate vesting
- Flexible Time Off, including one week off in the summer and one week off around December holidays
- 11 paid company holidays per year
- An opportunity to do truly meaningful work to make a lasting impact
- Longboard Perks (on-site gym, garage parking, company-sponsored events, etc.)
- Flexible spending account for medical care
- Life insurance, short and long term disability plans
TO APPLY PLEASE CLICK ON THE FOLLOWING LINK:
Vice President, Global Regulatory Affairs – Longboard Pharmaceuticals, Inc. – Career Page (applytojob.com)
