Description

Reporting to the Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs – CMC will be responsible for leading, developing, and executing CMC regulatory strategies on programs ranging from early to late-stage development, including preparation and filing of IND and NDA/MAA submission. This position will sit on cross function teams and will work closely with manufacturing, quality, and supply chain teams. This position is a hands-on role, providing both strategic and operational activities to support regulatory needs across multiple therapeutic areas.

To be successful in this role, you must be able to provide sound regulatory guidance, communicate clearly (in verbal and written form), and display exemplary organizational / leadership skills. In addition, the successful candidate will support an environment in which the team is highly motivated and engaged to work collaboratively within their team and cross functionally to deliver exceptional results and ensure long-term success.

This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).

Responsibilities

• Develop and implement effective CMC regulatory strategies for submission (i.e. IND/CTA/NDA/MAA) and identify regulatory risk and mitigation strategies.
• Manage all CMC interactions with the global Health Authorities including initial IND/CTAs, NDA/MAAs, supplements and variations, and any other key areas of discussions.
• Ensure the CMC regulatory strategy is aligned with global Health Authority requirements and review documents for submission readiness to ensure that all submission conform to relevant guidelines.
• Responsible for compilation, review, and approval of CMC submission documents for INDs/CTAs/NDAs/MAAs as well as any responses to queries from global Health Authorities.
• Review and evaluate proposed manufacturing and quality changes for global impact to ongoing and existing applications and provides strategic regulatory guidance for optimal implementation of changes.
• Ensure that CMC content in regulatory applications is complete, well-written, and meets all relevant requirements for the program’s development phase.
• Partner closely with manufacturing and quality teams providing strategic advice on complex technical and regulatory CMC topics.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.

• BA/BS Degree required in a health/life sciences or related field with 12+ years' experience with minimum of 8 years of global CMC regulatory experience. Advanced scientific degree preferred in the sciences, or health related field or equivalent.
• CMC regulatory experience in the pharmaceutical and/or biotech industry is required.
• Strong Knowledge of current US, EU, and other global market requirements.
• Experience in representing teams in front of global Health Authorities (i.e. FDA, EMA, etc.).
• Experience in filing NDAs/MAAs globally.
• Experience in the ability to deliver high quality CMC submission documents, including experience in writing and compiling Module 3 and corresponding Module 2 documents.
• Strong strategic skills including demonstrated ability to make complex decisions.
• Proven success in simultaneously handling strategic and transactional responsibilities, especially in a small-team environment.
• Demonstrated excellence in project management with a proven track record of effectively managing multiple projects / priorities simultaneously.
• Exceptional written and oral communication skills.
• Ability to work cross-functionally and creating strong partnerships with key stakeholders.
• Ability to work in a fast-paced environment with a strong attention to detail and have the agility to multi-task successfully.
• Previous experience supporting Health Authority GMP inspections is preferred.
• Managerial and personal development experience preferred.

Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

The annual base salary for this role is $260K – $270K. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.