Regulatory Submission Manager | REMOTE
We are seeking a Regulatory Submission Manager to support global regulatory initiatives and ensure compliance with regulatory requirements for investigational and marketed products. Role involves working closely with cross-functional teams and regulatory leads to support submission activities, labeling development, and strategic regulatory guidance. The ideal candidate has a strong background in regulatory submissions and document review, as well as experience collaborating with Regulatory Operations and external partners.
- 5+ yrs. of Regulatory Affairs experience in the Pharma/Biotech industry
- Proven experience w/regulatory submissions, including INDs & CTAs
- Strong background reviewing & editing regulatory documents
- Bachelors Degree Required
location: Telecommute
job type: Contract
salary: $65.00 - 79.61 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Provide regulatory support for investigational and clinical trial applications (IND, CTA, NDA, BLA, etc.)
- Work closely with Global Regulatory Lead (GRL) and cross-functional teams to ensure regulatory strategies align with project objectives
- Support the development and implementation of US product labeling by providing guidance on regulatory precedents
- Collaborate with Regulatory Operations and CROs to coordinate regulatory submissions
- Contribute to major regulatory filings, including initial INDs and NDA/BLA submissions
- Ensure compliance with applicable regulations, guidelines, and policies while interpreting regulatory requirements
- Build and maintain relationships across teams to streamline regulatory processes
qualifications:
- PhD or PharmD with 2+ years of regulatory affairs experience, MS with 4+ years, or BS with 5+ years
- Strong understanding of global regulatory guidelines and submission processes
- Excellent project management, organizational, and planning skills
- Solid oral and written communication skills with the ability to represent regulatory affairs in cross-functional teams
- Ability to work independently with minimal supervision while collaborating effectively with diverse stakeholders
- Demonstrates a problem-solving mindset and ability to generate innovative solutions in regulatory strategies
skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, 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 health, an incentive and recognition program, and 401K contribution (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 in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
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.
