Director/ Senior Director, Regulatory CMC

Vor Bio•Boston, MA

1d•$200,000 - $265,000

About The Position

Vor Bio is seeking an exceptional and highly motivated CMC leader, Director/Sr Director Regulatory CMC, to join our team. The qualified candidate will work cross-functionally to lead the development and implementation of robust regulatory CMC strategies and tactics across programs and lifecycle stages to support our company objectives. As a result, the candidate will play a vital role in helping to progress our lead program, telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, through clinical development and global registration. The candidate must be a highly effective leader as they will be relied upon to drive robust CMC strategic plans throughout development. This individual should also have strong interpersonal skills and a demonstrated track record with regulatory agencies. Extensive experience in the development of biologics and combination biologic/device products is a must.

Requirements

PharmD or PhD preferred with ≥8 years of industry experience in Regulatory CMC biologics.
Strong scientific background and training in manufacturing processes and development and development of combination biologic/device products are required.
Small molecule and medical device experience are a plus.
Experience working with FDA sCDER is required.
A strong background & track record in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management in the area of biologic medicinal products.
A broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution in US/ex-US.
Experience interfacing with FDA, and other global health authorities.
Demonstrated risk identification and critical thinking skills.
Strong understanding of the global pharmaceutical drug development and regulatory environment, including anticipating future trends and opportunities in biologics.
Ability to interact effectively across all levels of the organizations; integrates functional expertise with business knowledge to solve problems, meet priorities and deadlines in alignment with corporate goals and objectives.
Recognized as an influential leader who possesses a cross-functional collaborative skill set.
Strong oral and written communication skills with strong attention to detail and the ability to coordinate multiple activities in a faced paced biotech environment.
Able and willing to author regulatory documents as needed and provide guidance to subject matter experts on authoring regulatory appropriate CMC reports and assessments.

Nice To Haves

Small molecule and medical device experience are a plus.

Responsibilities

As a member of the CMC project teams, act as Regulatory CMC Lead for assigned programs providing strategic guidance to development team(s) on complex regulatory CMC topics.
Responsible for leading negotiations with regulators as applicable for initial INDs/CTAs, amendments and future marketing registration applications.
Accountable to establish and execute high-quality CMC related submissions including INDs/CTAs or amendments working in collaboration with other stakeholders (ie., research process & analytical development, manufacturing, and other SME’s).
Keep abreast of and communicate CMC regulatory requirements to ensure all development activities follow applicable regulations and guidelines.
Provide regulatory strategic and tactical support for CMC aspects such as change control & inspection management. Assess proposed manufacturing process changes, provide expertise on raw materials management, DP/DS specifications and release, process characterization & validation, methods development & validation and provide strategic regulatory guidance to enable implementation.
Participate in regulatory intelligence activities as they pertain to global CMC regulations and guidance and integrate into program plans.
Maintain responsibility for all CMC Regulatory timelines, that also includes managing contract staff and vendors relevant to CMC activities.
Build and maintain strong relationships with internal and external stakeholders.