Senior Project Manager, Regulatory

Salary: $152,000 - $160,000 / yearly DOE

Title: Senior Project Manager, Regulatory

Overtime Status: Exempt

Employment Status: Full-Time

Pay Range: $152,000 - $160,000 / year DOE

The hiring pay range for this position is $152,000 to $160,000 per hour based on skills, education, and experience relevant to this role.

Inventprise is a mission-driven bio-pharmaceutical company addressing global health inequalities by empowering people to live healthy lives. We do this by developing novel vaccines targeting infectious diseases for which there are no current preventive interventions or by optimizing currently marketed vaccines to provide a broader spectrum of protection, making them cheaper and more stable than before. We aspire to provide breakthrough public health interventions for all populations, globally. Inventprise is led by pioneers in vaccine discovery, seasoned experts in manufacturing and vaccine development, and proven commercialization veterans.  

At Inventprise, we believe our people are our most valuable asset. We are strongly committed to a range of workplace programs that support the well-being, growth, and engagement of our employees and our business. What we offer:

Benefits:

Effective the first of the month following the date of hire, employees are eligible to participate in the following Inventprise employee benefit programs:

• Medical, Dental, Vision, FSA, or HSA:  Currently Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and enrolled spouse and dependents.  Medical plans are currently provided through Premera Blue Cross.
• 401(k) program: Inventprise contributes 3% of employee base pay each pay period to their 401(k) account. Employee contributions are at the discretion of the employee.
• Paid Time Off: Employees start PTO accruals at the rate of 5.83 hours each pay period - annualized equivalent of 140 hours/year.
• Paid Holidays: Inventprise offers 9 paid holidays each year: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Day after Thanksgiving Day, Christmas Day, and two floating holidays.
  
• Stock & Bonus Plans: Employees are eligible to participate in the Company’s Bonus and Stock Award Plans.

Summary:

Inventprise is a biopharmaceutical company leveraging its innovative platform technology to develop vaccines against infectious diseases with an initial focus on invasive pneumococcal disease. Inventprise platform technologies are designed to enable high valent vaccines to induce broad, robust, and durable protection against pathogenic strains of infectious diseases. Inventprise has a robust pipeline of investigational vaccines including candidates to prevent group B streptococcus (GBS), Haemophilus influenzae type A (Hia), and Shigella. Based in the Seattle-area, Inventprise was founded by Subhash Kapre, PhD in 2012 to advance novel, affordable and highly impactful vaccines using proprietary technology, with the initial goal of providing lifesaving interventions globally, including low and middle-income countries. Inventprise maintains facilities in Redmond and Woodinville, Washington.

Inventprise seeks to hire a Senior Project Manager Regulatory Affairs with industry experience in drug development, particularly in the interaction with regulatory agencies. This position will report to the Associate Director of Regulatory, within the Clinical/Regulatory function, and play a key role in leading, developing, and implementing the preparation of submissions to regulatory authorities for the company’s vaccine programs. The successful candidate will also interface with the various cross-functional teams and management and will support interactions with key contacts at vendors, external partners, and stakeholders.

The successful candidate will be highly self-motivated, productive, a quick learner, and creative. They will have excellent problem-solving skills as well as strong written and verbal communication skills. This position requires an independent strategic thinker motivated by performance excellence and team success, someone who can roll up their sleeves and assist where needed, working within a lean Clinical and Portfolio Management team, and partnering with employees at all levels of the organization. The successful candidate will be a positive and enthusiastic team player, able to work with moderate guidance and take pride in the quality and timely delivery of their work

Essential Functions:

• Project management of regulatory submission timeline, including key document development required for regulatory submission.
• Develop, prepare, maintain and/or co-ordinate regulatory submissions to various regulatory agencies for products in early development.
• Review Clinical/Non-Clinical documents, Protocols, CMC documents, analytical methods and product test results and provide input.
• Provide regulatory representation on global program development teams.
• Support AD Regulatory in the preparation and coordination of INDs, CTAs in accordance with applicable regulations.
• Work extensively with contract research organizations for ex-US regulatory submissions.
• Contribute to CMC modules of the IND and CTAs would be an asset.
• Coordinate product label development based on regulatory requirement for US and ex-US markets.
  

Education, Experience & Skills:

• Minimum of a BS required, advanced degree in related scientific field preferred.
• 5 + years of Clinical Regulatory Affairs experience in drugs or biologics with a Biotech/Pharma or CRO.
• Immunology, Infectious Diseases and/or Vaccine experience preferred.
• Strong critical and objective interpretation of scientific information.
• Strong Project Management skills.
• Strong planning mindset and ability to set and drive strategy and timelines. Expert planning and tracking skills, able to see big picture, well-organized, focused on results, capable of managing multiple projects, excellent time and self-management.
• Solid understanding of FDA regulations and guidances; experience with additional regions is an asset (ie. EMA, Canada, WHO).
• Experience developing dossiers, including INDs, BLAs, MAAs, briefing documents, etc.
• Experience writing summaries for clinical pharmacology, efficacy, clinical safety, and non-clinical portions of regulatory submissions.
• Regulatory technical writing to support US/EMA submissions, clinical trial applications.
• Experience with Smartsheet or other project management tools (e.g., MS Project) an advantage.
• Very strong interpersonal skills, able to bridge between scientific and business team members, negotiate timelines and develop effective international collaboration.
  
• Strong verbal communication; expert in written communication.
• Expert team player. Requires the flexibility and collaborative skills to best manage change and differing opinions with diplomacy and competence. Development timelines are very aggressive and multi-faceted; position can be stressful and demanding.
  
• Smartsheet, Microsoft Project Professional, Excel, PowerPoint & Word.
  

Licenses/Certifications

 

• Regulatory Affairs Certification preferred.

Physical Demands:

 

• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
• Carrying, handling and reaching for objects.
• Ability to sit or stand for long periods of time while travelling.
  

Working Conditions:

 

• Candidate will execute Full-Time onsite job; flexible work schedule would be preferred occasionally.
  
• This position is substantially performed in a laboratory work setting with some office environment setting. On occasions, it will require heavy lifting, access to the warehouse, laboratories, or manufacturing environments.

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.

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