Director, Regulatory Operations

Zenas BioPharma • Waltham, MA

5h • $190,400 - $238,000 • 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 Director, Regulatory Operations, will be responsible for day-to-day submission management activities of early/late phase investigational products, leads submission management IND/CTA/amendments and future marketing application submissions, provides RIM and doc level publishing support and liaisons with 3 rd party publishing vendor for submission. The Director, RO participates in a cross-functional team, partners with key internal/external team members/stakeholders, and partners with Regulatory Affairs, Regulatory CMC and Medical Writing to ensure the scientific data and submissions fulfills agency expectations in a compliant manner. Support Veeva RIM updates and user training. This position will report to the Senior Director, Regulatory Operations.

Requirements

• 8+ years of direct Regulatory Operations experience.
• Bachelor’s degree in a relevant field or equivalent experience (10+ years in a regulatory affairs function); Master’s Degree is a plus
• Comfortable working in a demanding, fast-paced, start-up culture with evolving processes.
• Flexible and able to adapt to new situations as the business demands.
• Ability to work effectively in hybrid model from virtual home and in office settings.
• Demonstrate flexibility to work non-traditional work hours when needed, given international operations across time zones.
• Positive attitude, excellent project and information management skills, overall communication which includes written, verbal and interpersonal (non-verbal communication) and intent listening
• Proficiency in Veeva RIM (day to day knowhow as business admin (super user))
• Advanced computer skills in Adobe Acrobat and Office 365 Programs, including SharePoint, strong organization skills and thorough attention to details.
• Strong analytical and problem-solving skills
• Works independently as well as in a team environment

Nice To Haves

• Master’s Degree is a plus
• Experience with configuration changes, user training a plus.
• Experience with eCTD Publishing and viewer tools use, implementation a plus.
• Experience with StartingPoint Authoring Templates.
• Experience with Docshifter a Plus.

Responsibilities

• Manage IND, NDA, BLA and MAA submissions (all types, i.e. Clinical, CMC, Nonclinical, etc.) per Zenas BioPharma business priorities and liaise with eCTD vendor to deliver final submission components to be submitted to relevant global health authorities.
• Quality control checks on electronic common technical (eCTD) components, final submissions, document formatting, hyperlinks and bookmarks and ensure submissions adhere to local health authority guidelines.
• Maintain and update regulatory information management (RIM) system including submission records, SCP, documents, archival of electronic and hard copy submissions and correspondence.
• Build and track regulatory information management records including regulatory objectives, commitments and planned meetings and legacy data (if applicable).
• Ensure clinical studies, nonclinical studies, drug product / substance manufacturers are logged appropriately in regulatory information system.

What This Job Offers

• Job Type: Full-time
• Career Level: Director