Regulatory Affairs Specialist

About Inventprise

At Inventprise, developing innovative and widely available vaccines is in our DNA. By producing targeted vaccines for populations worldwide, we're addressing global health inequalities and empowering people to live healthy lives—no matter where they live. Headquartered in Redmond, WA, our goal is to deliver affordable, effective vaccines at large scale to Low and Middle-Income Countries, as well as populations in the U.S. and around the world. Inventprise is committed to creating a diverse and inclusive workplace, where our people are inspired to do their best work. We’re proud to have some of the world’s most qualified industry scientists, researchers, and manufacturing professionals on our team, and strive to create a vibrant, dynamic presence in the Washington State Life Sciences environment.

What the Role Offers - Regulatory Affairs Specialist

The Regulatory Affairs Specialist will produce regulatory-compliant documents to support Inventprise’s vaccine programs and will be responsible for managing competing priorities across multiple programs. This individual will work across multiple projects and need to develop strategies to meet deadlines.

What You Need to Succeed

• Contribute to the authoring of regulatory documents (e.g., IND/IMPD, BLA/MAA, health authority questions, briefing documents) to support the timely submissions of investigational and marketing applications.
• Contribute to global regulatory writing strategy for CMC content and drive CMC content requirements on assigned projects.
  
• Support non regulatory writing projects such as white papers, SOP and technical reports across multiple functional areas
  
• Maintain an up to date knowledge of style guides and ensures compliance across various documents.
• Develop timelines, prepare and manage the review and approval of submission-ready documents.
  
• Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations.
• Critical review of submission documents to ensure messaging is clear and consistent within and across documents.
• Well-versed in formatting using Microsoft Word and authoring tools, and performing final copyediting checks of documents.
  

Required Qualifications:

• BS required and 2 experience in regulatory affairs preferred.
• Strong organizational skills, with the ability to manage multiple projects simultaneously.
• Excellent writing, editing, and proofreading skills, with a keen eye for detail.
• Adaptability to changing requirements across various jurisdictions, and willingness to learn.
  
• Strong communication skills, and ability identify and escalate risks in a timely manner.
  
• Project management skills and ability to set and drive strategy and timelines preferred.
  
  

Physical Demands:

• Frequently use of office equipment that requires manual dexterity to operate (i.e. computers, phones, etc.).
• Occasional carrying, handling, and reaching for objects up to 30 pounds.
• Frequently sit or stand for long periods of time.
  
  

Mental Demands:

• Requires operational discipline to consistently focus and execute work-related tasks, with a minimum of human error and supervision. This involves self-checking of work immediately upon completion, and the ability to find / correct errors.
  
• Ability to elevate potential concerns/discrepancies to supervisors or management in a timely fashion.
  
• Ability to manage time effectively to coordinate multiple projects simultaneously required.
  
• Ability to use problem-solving techniques to ensure project goals are met.
  
• Effective communication skills both verbal and written are necessary to communicate within different departments and with external clients, maintaining a professional demeanor.
  
• Ability to adhere to ethical standards of conduct as well as applicable state and federal laws.
  
  

Working Conditions:

• Hybrid position with occasional visits to our Redmond or Woodinville facilities in WA State.
• Ability to travel between sites by own car, if needed to support workflows.
• When onsite, incumbents may be subjected to moving mechanical parts, odors, chemicals, extreme temperatures, inadequate lighting, workspace restrictions, and intense noises.
  
  

Estimated Base Salary: $77,000 - $87,000 Yearly DOE

Benefits:

• Medical, Dental, Vision, FSA, or HSA: Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and their enrolled spouse, and dependents. Medical plans are currently provided through Premera Blue Cross.
• 401(k) program: Inventprise offers both pre-tax 401(k) and post-tax Roth retirement savings plans, letting you decide how you want to save for the future. We also make an employer contribution of 3% of your total earnings each pay period, regardless of whether you contribute.
• Paid Time Off: Generous PTO, in addition to paid holidays.
• Stock & Bonus Plans: Employees are eligible to participate in the Company’s Bonus and Stock plans.

Our People-First Philosophy

At Inventprise, you’ll be part of a world-class team working on innovative vaccines and technologies that have global impact. Our people are an integral part of our strategy, allowing us to grow as a company and improve our performance year-over-year.
Our company was built on the belief that by working together, we have the ability to make the world a better place and improve lives. We have a growth mindset and are constantly looking for ways to enhance our contributions to improve global health. We believe that when we support each other and set high standards, we are able to do our best work.

Equal Opportunity Employer

Inventprise is an equal-opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender, identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

Salary : $77,000 - $87,000