We are seeking a Drug Safety associate with previous direct hands-on experience with post-marketing regulatory activities (i.e. AR, CBE-30, PAS, Variations) for biologic and/or drug products.
The individual in this role will be reporting to the Director, Global Regulatory CMC, this position will provide Regulatory CMC support for Biologics.
Scope of Responsibilities:
- Interacts with RA colleagues world-wide
- 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
- Coordinates and prepares regulatory document packages to support pre- and post-market change
- 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).
Must Have Skills:
- 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
Education:
- Bachelors or Master’s degree in the Life Sciences or Engineering and at least 5 years of experience in regulatory, manufacturing, technical development or QA/QC
- In-depth knowledge of regulatory requirements for biopharmaceutical development and manufacturing.
Preferred Qualifications :
- BS, MS or PhD in Biology, Chemistry, Engineering or related field
- 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