Senior Director, Global Regulatory Lead

Liquidia Corporation; North Carolina; On-site; USD 150,000 - 220,000; Full time

Job summary

Liquidia Corporation seeks a Senior Director, Global Regulatory Lead to design and implement regulatory strategies for drug development. This high-impact role requires extensive experience in regulatory affairs, focusing on compliance, submissions, and collaboration with global health authorities. Candidates are expected to possess a strong background in the biopharma industry, ready to navigate complex regulatory landscapes and enhance overall corporate objectives.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Savings Retirement Plan

Unlimited Paid Time Off

Qualifications

• Minimum 10+ years of experience in regulatory affairs.
• Proven experience in bio-pharma and biotech environments.
• Strong knowledge of FDA and EMA regulations.

Responsibilities

• Lead implementation of regulatory strategies and development programs.
• Maintain relations with regulatory agencies for timely approvals.
• Develop regulatory plans and timelines with cross-functional teams.

Skills

Regulatory Affairs

Interpersonal Skills

Project Management

Clinical Intelligence

Education

BA/BS in Health/Life Sciences

Advanced Degree

RAC Certification

Tools

Microsoft Office Suite

VEEVA

Job description

Join to apply for the Senior Director, Global Regulatory Lead role at Liquidia Corporation

Join to apply for the Senior Director, Global Regulatory Lead role at Liquidia Corporation

Direct message the job poster from Liquidia Corporation

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

Job Summary

The Senior Director, Global Regulatory Lead (GRL) is responsible for developing and executing a cohesive Regulatory Affairs strategy and compliance through effective optimization and integration of all functional groups internally and externally to ensure timely and successful interactions with global health authorities to meet business objectives for clinical and commercial assets.

Responsibilities

• Lead the implementation of regulatory strategies and plan and guide development program planning to anticipate changes in regulatory environment and approval requirements.
• Lead US FDA and ROW filings (including Europe and China) for global clinical development in adults and pediatrics for drug and delivery device combination product. Highly effective at working with a cross-functional team to achieve corporate, department, and program goals.
• Advise program asset leadership and senior management on status of Regulatory Affairs strategies, plans, tactics, procedures and practices.
• Establish and maintain relationship with regulatory agencies, actively leading and participating in interactions and submissions to secure necessary approvals and licenses.
• Develop and maintain excellent knowledge of regulatory policies, guidance, and environments; establish and maintain an effective network with relevant policy makers, key opinion leaders and regulatory agencies within the assigned disease area.
• Interpret and communicate health authority correspondence effectively and quickly to senior leadership and project teams.
• Advise and participate in the development and implementation of SOPs for regulatory affairs and clinical research/trials and related activities.
• Develop and own regulatory plans and timelines and assign and manage cross-functional team effectively to ensure all projects are appropriately prioritized and business objectives met.
• Author and review sections of key regulatory documents in support of development and marketing applications in conformance with local regulatory requirements.

Requirements

Education and Experience

• BA/BS degree required, preferably in a health/life sciences or related field. Advanced degree and RAC/similar certification preferred.
• Minimum 10+ years of industry experience with increasing responsibilities in regulatory affairs is required.
• Proven experience and knowledge in leading and executing in bio-pharma and/or demonstrated movement from large/medium pharma organizations to biotech.
• Business travel 10-20% as required.

Knowledge, Skills, and Abilities

• Previous experience with regulatory filings and interactions with US FDA and EMA in support of pre- and post- approval development initiatives. LATAM and Asia experience (ie China) ideal but not mandatory. Strong preference for CTIS experience.
• Experience with global clinical trials global registration (NDA/BLA/MAA), and GxP and ISO/EU MDR for delivery device in support of combination product standards. Recent experience preferable.
• Recognized internally and externally as an expert in regulations, guidelines and precedents related to clinical and pharmaceutical development, labeling and promotion.
• Substantial knowledge and experience with regulatory affairs and regulations; demonstrated ability to develop and maintain excellent working relationships with regulatory authorities.
• Demonstrates current knowledge of global regulatory changes and impacts to the organizational practice and the market.
• Experience appearing before regulatory agencies and health authorities with the demonstrated ability to interact and present effectively, to anticipate and respond to questions and to report back to senior management and colleagues.
• Clinical intelligence and understanding sufficient to interact and communicate at a scientific level in discussions; highly attuned on the clinical side with the ability to manage and even advise, as appropriate.
• Compelling interpersonal verbal, written and presentation skills in communication with internal and external customers.
• Strong management and organizational skills with an ability to prioritize and enable and accelerate multiple programs and projects.
• Software skills including Microsoft Office Suite products, VEEVA or similar regulatory information management software.

Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!

Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

Recruiting Agencies, Please Note :

Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Strategy/Planning, Project Management, and Research

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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