Global Regulatory Affairs - CMC
Bridgewater, New Jersey, US Bridgewater, NJ 8807
Job Title: Global Regulatory Affairs - CMC
Location: Bridgewater, New Jersey, US
Job Type: Contract
Duration: 5+ Months
- Main responsibility will include monitoring and tracking regulatory information and assuring accurate communication of the current status of post-approval change control assessments and submissions; ensures all databases are up-to-date and accurately reflects registered information.
- May support global regulatory submissions such as annual reports, PAS, CBE supplements, variations, registration renewals, response dossiers, etc.
- Interacts with RA colleagues world-wide;
- May provide project team representation while working closely with site Manufacturing, Quality, Technical Support/service groups to compile required information in accordance with established timelines;
- May coordinate and work with sites to prepare regulatory document packages to support post-market changes
- May provide project team representation, consults on regulatory project needs and is responsible for developing required regulatory documentation/submissions.
- May review technical documentation (i.e., Change Controls); Recommends/approves changes for manufacturing and compliance, ensuring conformance with existing regulatory approvals;
- Bachelors or Masters degree in the Life Sciences and at least 2-5 years of experience in regulatory, manufacturing, technical development or QA/QC
- In-depth knowledge of regulatory requirements for biopharmaceutical development and manufacturing.
- BS, MS or PhD in Biology, Chemistry 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
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Recruiter: Rahul Lahiri