Senior Director, Regulatory Affairs CMC

Zenas BioPharma•Waltham, MA

13h•$220,000 - $275,000•Hybrid

About The Position

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas’ earlier stage programs include a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor. We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation! Position Summary: The Sr. Director, Regulatory Affairs CMC (Chemistry, Manufacturing and Controls) will be responsible to ensure that Zenas is executing global regulatory CMC strategies to support clinical development of small molecule drug products. The individual will provide regulatory guidance and lead the development and implementation of short and long-term regulatory strategies for assigned projects and programs. The individual will be responsible to lead the writing and reviewing of CMC sections of regulatory submissions (IND/IMPD/NLA) to meet both global quality expectations and company timelines. The ideal candidate is a Regulatory Affairs CMC specialist with prior experience with small molecule API and drug products. The Sr. Director, RA CMC participates in a cross-functional team, partners with key internal/external stakeholders in Technical Operations, Quality, and Regulatory Affairs to ensure the scientific data and submissions fulfill agency expectations in a compliant manner. This position will report to the Vice President, Global Regulatory Affairs CMC

Requirements

A BS, or advanced degree, preferably in chemistry or life/physical sciences
A minimum of 12 years regulatory affairs experience (5+ years RA CMC) within the pharmaceutical or biotechnology industry
Prior experience in developing US and EU global regulatory strategies for small molecule drugs
Knowledge of small molecule chemistry and development processes
Prior experience in compiling module 3 CMC sections for IND/IMPD/NDAs
Experience interacting with key functional stakeholders (product development, manufacturing, QA, QC, supply chain)
Ability to influence across functions and levels within the organization.
Self-motivated, self-disciplined and able to function independently as well as part of a team
Ability to prioritize, multi-task, and work in an evolving and high-pressure environment
Good presentation and excellent written/verbal communication skills
Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.

Nice To Haves

Experience managing people preferred

Responsibilities

Lead the development of the regulatory CMC strategy for assigned development products
Represent RA CMC on development teams and provide direction on the interpretation and application of CMC/Quality regulations and guidance documents.
Prepare/coordinate/review the CMC content of IND/IMPD/NDA submissions, meeting packages and response to regulatory agency questions and requests.
Lead teams for assigned CMC submission projects per agreed upon/required timelines.
Provide strategic and regulatory compliance input on technical protocols, reports, and other source CMC documents.
Ensure alignment of the regulatory CMC strategy with the corporate objectives through communication and collaboration with internal stakeholders and business partners. Escalate issues to Senior Management that may impact regulatory compliance and continued development of assets.
Maintain a current knowledge of US and EU regulatory guidance, regulations, and competitive intelligence. Communicate key updates to Senior Management and project teams as appropriate, and ensure Zenas’s regulatory submissions comply with all regulations/guidelines.
Represent Regulatory Affairs CMC on various cross-functional teams.
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
Perform other regulatory related duties as assigned