Associate Director, Regulatory Affairs Operations
If you find science, speed, and success exhilarating, you have come to the right place.
Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax is uniquely qualified to address the enduring need for innovative vaccines. We utilize our proprietary recombinant technology platform, which combines genetic engineering's power and speed to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.
We are seeking an Associate Director of Regulatory Operations to join our Regulatory Affairs department in Gaithersburg, MD. Will consider remote based employee for the right person! The position will work in in close collaboration to support and assist the Head of Regulatory Operations to implement and coordinate all aspects of regulatory activities as needed to support the continued development and approval of Novavax's products. The position shall lead the Regulatory Operations Submissions Team in completing regulatory correspondence and submissions.
This position will be reporting to the Director, Regulatory Affairs Operations.
Responsibilities include but are not limited to:
- Develop and implement Regulatory Operations tools, processes, and strategies
- Manage Regulatory Operations Submissions Team and coordinate workload for various programs including external vendors and consultants
- Responsible for formatting, publishing, and submitting Regulatory documents in CTD and eCTD format and managing life-cycled submissions, such as INDs; MFs; and BLAs in the US, and MAAs and CTAs in Europe – includes organizing the submission security, review process, submission content planning, and reviewing submissions for completeness and appropriateness
- Coordinate submissions in a team-setting in time-intensive situations
- Develop and maintain style guides, templates, and Standard Operating Procedures related to Regulatory Operations activities
- Provide intra- and inter-departmental training on preparing submission-ready documents, electronic publishing, and submissions
- Other duties as assigned
- BS or BA degree
- 10 years in Regulatory Operations with a minimum of 5 years in Regulatory Submissions
- 2 years of previous people management experience
- Comprehensive knowledge of drug development process, drug laws, regulations, and guidelines
- Previous experience developing eCTD-compliant submissions using validated content management and publishing systems
- Proficient in major Regulatory Operations e-submission software (e.g., Adobe Acrobat, US FDA ESG), as well as Microsoft Office Suite (e.g., Word, Excel, PowerPoint)
- Familiarity with CTD, ICH, GCP, and other standards
- Ability to work independently and within a group setting and to interact effectively with different functional departments
- Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems
- Ability to establish and build collaborative relationships with staff, colleagues, and regulatory authorities to support developmental programs
- Possesses strong critical and logical thinking
Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.
Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.
Equal Opportunity Employer/Veterans/Disabled
Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.