Drug Safety Associate

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 

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