Director, Regulatory Operations
About The Position
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 3rd 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)) Experience with configuration changes, user training a plus.
- Experience with eCTD Publishing and viewer tools use, implementation a plus.
- Experience with StartingPoint Authoring Templates.
- 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 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.
Benefits
- The position is eligible for a competitive compensation and benefits package.
- Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.
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What This Job Offers
Job Type
Full-time
Career Level
Director
