Drug Safety Associate

  We are seeking a Drug Safety Associate that will be reporting to the Manager, Global Regulatory CMC, this position will provide Regulatory CMC support
   
 The 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.

Scope of Responsibilities:

   
  • 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; 
  • Coordinate and work with sites to prepare regulatory document packages to support post-market changes 
  • Provides project team representation, consults on regulatory project needs and is responsible for developing required regulatory documentation/submissions.  
  • Review technical documentation (i.e., Change Controls); Recommends/approves changes for manufacturing and compliance, ensuring conformance with existing regulatory approvals; 



Must Have Skills/Experience:

 
  • 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 

Education/Training:

 
  •  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.    
 

About us:

We are not a large corporate consulting conglomerate, we are a small and steadily growing valuable consulting firm. -Valuable to our clients and consultants we work with. We have an excellent reputation with our clients and one that we continue to build upon. We are always looking for top talent. 

Want to apply later?

Type your email address below to receive a reminder

Apply to Job

ErrorRequired field
ErrorRequired field
ErrorRequired field
Error
Error
insert_drive_file
insert_drive_file