JobsUSARegulatory Senior Project Manager (PMO)
Company : Volt
Location : San Rafael, CA
Posted Date : 15 September 2025
Job Type : Full Time
Category : Project Management
Occupation : Project Manager
Job Details
Innova Solutions has a client that is immediately hiring for a Regulatory Senior Project Manager (PMO)
Position type: Full time Contract
Duration: 12 months
Location:Remote
As a(n) Regulatory Senior Project Manager (PMO) you will:
As part of the client R&D Project Management Organization (PMO), the Regulatory Senior Project Manager supports and drives the efficiency and effectiveness of Regulatory or cross-functional sub-teams in partnership with the Global Regulatory Lead (GRL) or team lead through meeting management, timeline development / management / tracking, and cross-functional communications.
PM responsibilities may include:
Strategy and Execution
Contribute to and support global Regulatory Affairs strategies and operations, ensuring that they align with program goals/objectives and input of the GRT with functional regulatory representatives
Track and drive for action item completion
Partner with GRL and functional regulatory leads to prioritize team activities and manage competing priorities
Develop regulatory project timelines in collaboration with functional regulatory leads and cross-functional stakeholders; maintain timelines from pre-clinical phase through product life cycle
Liaise with Project Managers in other functional areas to ensure regulatory timelines are integrated and linked to reflect cross functional dependencies
Document regulatory milestones/deliverables in the timeline(s) and report progress against team, department and corporate goals as needed
Prepare project and cross-project dashboards for teams/management, highlighting key regulatory activity such as submission and approval milestones, review periods, etc.
Track Regulatory submissions and approvals globally in the designated tracking system, if applicable for product
Track and monitor completion of commitments for duration of lifecycle maintenance and ensure timely status updates are made in the designated tracking system, if applicable for product
In partnership with Global Regulatory Lead (GRL), enforce guidelines of GRT Charter (or other relevant team charters)
Meeting Management & Support
Schedule GRT meetings, generate the agenda and facilitate the meeting (in collaboration with the GRL), and document/distribute minutes (including action items) according to GRT Meeting Best Practices
Schedule Regulatory Advisory Boards (RABs), facilitate the meeting (in collaboration with the GRL) and document/distribute minutes (including action items) according to RAB Charter
Provide high-level support to MA/IND/CTA Filing teams (and module teams as applicable)
For all other meetings (such as Advisory Committee, Paediatric Investigation Plan (PIP), or ad hoc), PM may document decisions and/or action items as needed
Cross-functional Leadership
Liaise across Regulatory teams, sub-teams, and cross-functional Filing Teams to ensure consistent communication and alignment
Communicate regulatory information and activities to stakeholders outside of regulatory and externally
Partner with various stakeholders to transition products from development to marketed stage
Represent Regulatory Affairs on Production Integration Management Team (PRIME) and align on deliverables/timeline with cross-functional PMs; provide input on Regulatory activities in the product dashboards created by the PRIME teams
Identify and implement opportunities for process improvement within Regulatory Affairs and the PMO
Education:
Education & Experience:
Degree in health or life sciences, including chemistry, molecular biology, or similar; Masters Degree or MBA preferred
6+ years with Masters/MBA, 8+ with bachelor's degree
Project Management in a Biotech or Pharmaceutical Company experience preferred
Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Thank you!
Namrata Gautam
PHONE: (+1)
EMAIL: PAY RANGE AND BENEFITS:
Pay Range*: $75- $80 per hour
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions:
- Named One of America's Best Employers for New Grads by Forbes (2024
- Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, )
- One of the Largest IT Staffing Firms in the US – Ranked #3 by Staffing Industry Analysts (SIA, 2024)
- One of the Largest Staffing Firms in the US – Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)
- Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
- One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)
- AWS Advanced Tier Services Partner with 100+ certifications
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) . Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions:
- One of Largest IT Consulting Staffing firms in the USA – Recognized as #4 by Staffing Industry Analysts (SIA 2022)
- ClearlyRated® Client Diamond Award Winner (2020)
- One of the Largest Certified MBE Companies in the NMSDC Network (2022)
- Advanced Tier Services partner with AWS and Gold with MS
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
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