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location: Framingham, Massachusetts
job type: Contract
salary: $38.25 - 45.01 per hour
work hours: 9 to 5
- Interacts with RA colleagues world-wide; Coordinates and prepares regulatory document packages to support pre- and post-market changes; Provides project team representation, consults on regulatory project needs and is responsible for coordinating and reviewing required regulatory documentation/submissions. Provides direction in managing information from/to other departments.
- Monitors and tracks information, ensuring accurate communication of the current status of post-approval change control assessments and submissions
- Reviews technical documentation; Recommends/approves changes for manufacturing and compliance, ensuring conformance with existing regulatory approvals; Responsible for determining if changes and deviations are in compliance with regulatory licenses (in all applicable countries).
qualifications: Basic qualifications:
- Bachelors or Master's degree in the Life Sciences or Engineering and at least 3 years of relevant experience in regulatory, manufacturing, technical development or QA/QC, or related fields
- In-depth knowledge of regulatory requirements for biopharmaceutical development and manufacturing.
- BS, MS or PhD in Biology, Chemistry, Engineering or related field.
- Excellent written and verbal communication skills.
- Solid understanding of GMPs, FDA regulations and ICH guidance pertaining to drug and/or biologic regulations.
- Strong understanding of manufacturing processes
- Excellent organizational skills, demonstrated ability to prioritize multiple projects.
- Ability to work in a team environment, possessing interpersonal skills to effectively work with other departments at various levels. Excellent communication skills and ability to influence across the broadest of constituencies.
- Have direct hands-on experience with post-marketing regulatory activities (i.e. AR, CBE-30, PAS, Variations) for biologic and/or drug products
- Ability to effectively interpret guidance and provide recommendation to key stakeholders.
- Regulatory, Manufacturing, QA/QC experience
- Proficient in MS Word, Excel, PowerPoint, MS Project.
- Ability to set ambitious and realistic targets, drive for results and build accountability.
- Ability to effectively manage the balance between delegation/empowerment and a hands-on approach
skills: Quality control, FDA, Quality Assurance, GMP (Good Manufacturing Practice)
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.