Global Regulatory Affairs - CMC

Bridgewater, NJ 8807

Job Category: Pharmaceutical Job Number: 151612

Job Description

Job Title:               Global Regulatory Affairs - CMC

Location:               Bridgewater, New Jersey, US

Job Type:               Contract

Duration:               5+ Months

Job Description:

  • 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;

Basic Qualifications:

  • 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.

Preferred Qualifications:

  • 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

About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities

Reach Out To A Recruiter

Recruiter:         Rahul Lahiri


Phone:               678-666-4354

Meet Your Recruiter

Subhasis Sahu
Resource Specialist

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