Director/Senior Director, Global Regulatory Lead

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 Global Regulatory Lead (GRL) is responsible for the development of a cohesive Regulatory Affairs strategy and direction through effective optimization and integration of all groups internally and externally. S/he will provide regulatory affairs counsel to internal stakeholders, maintain the regulatory dialogue with global regulatory authorities and interact with internal teams and external vendors in support of US and Global regulatory filings, clinical development activities as well as commercial activities. The GRL will assist in maintaining compliance with GCP standards for early and late stage clinical development to secure and maintain market access for product(s) in line with business objectives, and in coordination

Specific Duties, Activities, and Responsibilities

• Support US FDA/EU EMA/CTA and ROW filings for global phase 3 development. Highly effective at working with a cross-functional team to achieve corporate, department, and program goals.

• Advise program leadership and senior management on status Regulatory Affairs strategies, plans, tactics, procedures and practices.

• Lead the implementation of regulatory strategies and plan and guide development program planning to anticipate changes in regulatory environment and approval requirements.

• Advise clinical operations in the development and implementation of SOPs for clinical research/trials and related activities.

• Develop and own regulatory plans and timelines and assign and manage team effectively to ensure all projects are appropriately prioritized and key goals are met on time.

• Develop and maintain excellent knowledge of regulatory procedures and environments; establish and maintain an effective network with relevant policy makers, key opinion leaders and regulatory agencies within the assigned disease area.

• Development and review sections of IND, NDA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.

Education and Experience

• BA.BS degree required, preferably in a health/life sciences or related field.

• Minimum 8+ years of industry experience with increasing responsibilities in regulatory affairs is required.

• Global regulatory experience required.

• Proven experience and knowledge in leading and executing in bio-pharma and/or pharma organizations.

• RAC or similar certification strong preferred.

• A strong understanding of regulatory authority guidance, including ICH.

• Travel as required, expected to be up to 25%.

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 ideal but not mandatory.

• Experience with global phase 3 pivotal trials, NDA and MAA enabling studies, and cGCP standards.

• Recent NDA and/or MAA filings.

• 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 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.

• Computer skills including Microsoft Office Suite products.

Benefits

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.