Drug Safety Associate II
55 Corporate Drive, USNJ8100 Bridgewater, NJ
- Reporting to the Manager, Global Regulatory CMC, this position will provide Regulatory CMC support
- 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 provides 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;
- 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
- BS, MS or PhD in Biology, Chemistry or related field.
- Bachelors or Master’ s 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.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.