Director/Senior Director, CMC Global Regulatory Affairs
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.
The Director, CMC Global Regulatory Affairs is responsible for leading all regulatory CMC development, registration, and compliance activities from early development through commercialization. This position reports to the Vice President, Global Regulatory Affairs and is based at Liquidia in Research Triangle Park, North Carolina.
Principal Duties and Responsibilities:
- Work closely with CMC colleagues and cross-functional project teams to develop CMC regulatory submission strategies, review content, and maintain submission timelines to successfully meet business objectives.
- Assess and communicate CMC regulatory requirements to ensure all development activities comply with applicable regulations and guidelines.
- Work with CMC colleagues to develop Quality by Design (QbD) strategies for novel manufacturing processes. Assist in the conduct and appropriate documentation of all QbD related activities.
- Conduct risk assessments and develop mitigation strategies for global CMC regulatory matters.
- Author, prepare, and compile CMC sections of regulatory submissions (NDA/MAA, IND/CTA, reports or correspondences, annual reports, IND/CTA amendments) and ensure compliance with regulations and standards of health authorities around the world.
- Prepare responses to regulatory authority information requests during the review process to ensure product approvals.
- Interface with regulatory agencies on all CMC matters and lead preparations for regulatory agency CMC meetings.
- Effectively communicate novel manufacturing processes and QbD activities to regulatory agencies.
- Work closely with Manufacturing and Quality colleagues to prepare for GMP facility inspections by health authorities. Ensure all corrective actions are completed, documented, and properly communicated.
- Ensure that CMC-related changes are reported in a timely manner to health authorities in accordance with regulatory requirements.
- Maintain current knowledge of relevant regulations, including proposed, and final rules.
- Communicate knowledge of new and pending regulations, guidelines, and standards.
- Ensure overall operation is within the approved budget and timeline.
- Ensure maintenance of Liquidia’s high ethical standing.
- 3Bachelor’s degree in chemistry, biochemistry, engineering, life sciences or related field required. Advanced degree preferred.
- Minimum of 10 years CMC regulatory experience in the pharmaceutical industry.
- Ability to originate and execute CMC regulatory strategies with minimal oversight.
- Strong knowledge of drug development and life cycle management concepts and interdependencies with the overall development process.
- Small molecule experience.
- Understanding of and experience with pharmaceutical QbD concepts and techniques.
- Excellent knowledge of FDA and ICH requirements and guidelines, with experience as FDA liaison.
- Knowledge of EU regulations and guidelines preferred.
- Experience in authoring and filing INDs/CTAs/IMPDs and NDAs/MAAs.
- Experience in post-market and commercialization regulatory CMC activities.
- RAC certification preferred.
- Excellent written and oral communication skills. Demonstrated ability to communicate complex issues to diverse audiences.
- Proven evaluative, analytical, and interpretative skills enabling review and synthesis of information used in regulatory planning and submissions.
- Demonstrated project management skills.
- Capable of multi-tasking, setting priorities, and meeting timelines in a fast-paced, innovative environment with minimal supervision.
- Supervisory oversight of contract service providers, external consultants, and in-house project teams will be required.
- Able to communicate, influence, learn and teach horizontally and vertically within a multi-disciplined highly-matrixed organization.
- Demonstrated aptitude for ‘hands-on’ troubleshooting and problem solving with an exemplary history as a “self-starter”.
- Strong desire to work as part of many cross-functional teams consisting technical, scientific, and administrative team members.
- Unrelenting dedication to delivering high quality documents and results.
- Occasional travel will be required (<10%).
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.