Global Regulatory Affairs - CMC

  • location: Bridgewater, NJ
  • type: Contract
  • salary: $54.11 - $63.67 per hour
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job description

Global Regulatory Affairs - CMC

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!

location: Bridgewater, New Jersey
job type: Contract
salary: $54.11 - 63.67 per hour
work hours: 9 to 5
education: Bachelors
  • Reporting to the Director, 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 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 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.

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

skills: Quality control, MS-WORD, MS-EXCEL, MS-Project
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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