Pay Growth
?
out of 5
Not enough data
Not enough info to score pay or growth
Regulatory Submissions Project Manager
Job
Randstad USA
Remote
Full-Time
Review key factors to help you decide if the role fits your goals.
Job Security
?
out of 5
Not enough data
Calculating job security score...
Total Score
79
out of 100
Average of individual scores
Skill Insights
Compare your current skills to what this opportunity needs—we'll show you what you already have and what could strengthen your application.
Job Description
job summary: This 100% remote contract role offers a seasoned professional the chance to lead end-to-end planning and execution for major global marketing applications. You will manage critical NDA, BLA, MAA, and IND/CTA filings within a sophisticated global matrix environment, ensuring compliant, inspection-ready dossiers.
Demonstrated experience leading major regulatory approval filings such as NDA, BLA, MAA, IND/CTAs, or equivalent global marketing applications.
Experience operating in a matrixed global development environment, supporting complex cross-functional submission teams, and partnering with Research & Development project teams for IND/CTAs.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay 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. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. job detailssummary$110 - $120 per hourcontractbachelor degreecategorylife, physical, and social science occupationsreference53740job details job summary: This 100% remote contract role offers a seasoned professional the chance to lead end-to-end planning and execution for major global marketing applications. You will manage critical NDA, BLA, MAA, and IND/CTA filings within a sophisticated global matrix environment, ensuring compliant, inspection-ready dossiers.
Demonstrated experience leading major regulatory approval filings such as NDA, BLA, MAA, IND/CTAs, or equivalent global marketing applications.
Experience operating in a matrixed global development environment, supporting complex cross-functional submission teams, and partnering with Research & Development project teams for IND/CTAs.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay 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. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
location:
South San Francisco, California job type: Contract salary: $110 - 120 per hour work hours: 9 to 5 education: Bachelors responsibilities: Lead end-to-end planning and execution of major regulatory submissions, including original marketing applications, IND submissions for programs transitioning from Research into Development, supplements, amendments, responses to health authority questions, and other lifecycle submissions. Regulatory Affairs leadership, program teams, Research project teams, and submission stakeholders Develop and maintain integrated submission plans, milestones, critical paths, risk logs, and escalation pathways to support on-time and high-quality delivery across Development and Research transition activities. Cross-functional submission teams, program managers, and program leadership Coordinate cross-functional content readiness, deliverable ownership, review cycles, and decision forums to ensure compliant and inspection-ready dossiers, including strong collaboration with stakeholders and team members. Cross-functional submission teams, program managers, and program leadership Facilitate governance, submission readiness reviews, issue resolution, and communication of status, risks, and key decisions to stakeholders and senior leaders in partnership with program managers. Cross-functional submission teams, program managers, Research program managers, and matrix partners Support post-submission activities, rapid-response workflows, and continuous improvement of submission planning processes, tools, templates, and team ways of working, including adoption of best practices. Submission teams, Regulatory Operations, functional process owners, and established centers of excellence qualifications:Required:
Bachelor's degree in life sciences, pharmacy, regulatory affairs, or a related discipline required.8+ years of relevant pharmaceutical, biotechnology, or life sciences experience, including substantial demonstrated experience in regulatory submissions project management.Demonstrated experience leading major regulatory approval filings such as NDA, BLA, MAA, IND/CTAs, or equivalent global marketing applications.
Experience operating in a matrixed global development environment, supporting complex cross-functional submission teams, and partnering with Research & Development project teams for IND/CTAs.
Preferred:
Advanced degree #LI-KH1 skills:Project Management, FDA Submissions Equal Opportunity Employer:
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay 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. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. job detailssummary$110 - $120 per hourcontractbachelor degreecategorylife, physical, and social science occupationsreference53740job details job summary: This 100% remote contract role offers a seasoned professional the chance to lead end-to-end planning and execution for major global marketing applications. You will manage critical NDA, BLA, MAA, and IND/CTA filings within a sophisticated global matrix environment, ensuring compliant, inspection-ready dossiers.
location:
South San Francisco, California job type: Contract salary: $110 - 120 per hour work hours: 9 to 5 education: Bachelors responsibilities: Lead end-to-end planning and execution of major regulatory submissions, including original marketing applications, IND submissions for programs transitioning from Research into Development, supplements, amendments, responses to health authority questions, and other lifecycle submissions. Regulatory Affairs leadership, program teams, Research project teams, and submission stakeholders Develop and maintain integrated submission plans, milestones, critical paths, risk logs, and escalation pathways to support on-time and high-quality delivery across Development and Research transition activities. Cross-functional submission teams, program managers, and program leadership Coordinate cross-functional content readiness, deliverable ownership, review cycles, and decision forums to ensure compliant and inspection-ready dossiers, including strong collaboration with stakeholders and team members. Cross-functional submission teams, program managers, and program leadership Facilitate governance, submission readiness reviews, issue resolution, and communication of status, risks, and key decisions to stakeholders and senior leaders in partnership with program managers. Cross-functional submission teams, program managers, Research program managers, and matrix partners Support post-submission activities, rapid-response workflows, and continuous improvement of submission planning processes, tools, templates, and team ways of working, including adoption of best practices. Submission teams, Regulatory Operations, functional process owners, and established centers of excellence qualifications:Required:
Bachelor's degree in life sciences, pharmacy, regulatory affairs, or a related discipline required.8+ years of relevant pharmaceutical, biotechnology, or life sciences experience, including substantial demonstrated experience in regulatory submissions project management.Demonstrated experience leading major regulatory approval filings such as NDA, BLA, MAA, IND/CTAs, or equivalent global marketing applications.
Experience operating in a matrixed global development environment, supporting complex cross-functional submission teams, and partnering with Research & Development project teams for IND/CTAs.
Preferred:
Advanced degree #LI-KH1 skills:Project Management, FDA Submissions Equal Opportunity Employer:
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay 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. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.