Regulatory Affairs Specialist III

  • location: Bridgewater, NJ
  • type: Contract
  • salary: $71.82 - $84.50 per hour
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job description

Regulatory Affairs Specialist III

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: $71.82 - 84.50 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
The candidate is responsible for assisting in the post-approval maintenance of products within the portfolio of Regulatory CMC Small Molecule Marketed function.

Primary responsibilities will be the following:

- Marketed product support for global maintenance (US, EU and ROW) activities

o Assessment of change controls from Industrial Affairs and dossier requirements

o Ensure dossier publishing with Reg Ops with any necessary coordination with GRA Leads

o Creation of any response documents and coordination with all partners for completion

o Appropriate database management (VEEVA RT, etc.)

o Renewal activities according to current SOPs and Global Planning for all markets

- Variation Tracking with Affiliates

- Other support activities including administrative documents for all submission types

- eCTD Application Forms (MRP,CP, etc.)

Other activities such as below may be assigned based on the level and ability of the incumbent.

- Regional/Pharmaceutical Operations/Industrial Affairs sponsored non-R&D life-cycle management projects

- Territory extensions / new registrations

- Support of initiatives within Reg CMC

 
qualifications:
  • Minimum of a Bachelor's Degree; advanced degree (Masters, PhD) in a science/health field (eg, Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent, is desirable.
  • An understanding of Regulatory CMC and eCTD content Modules 1-3 through technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) or direct Regulatory CMC experience is required.
  • Global operational experience with a mid/large-size Regulatory CMC and Devices Organization.
  • Must have some knowledge of global regulations/guidelines, key Health Authority/Industry thinking and trends, and be capable of resolving strategic technical and regulatory issues.
  • Should demonstrate initiative, some independent thinking, anticipatory foresight, and be able to communicate effectively to internal and external audiences.
  • Fluency (oral and written) in English language is strongly recommended.
  • Potential to be able to mentor and train other contractors is desirable but not essential.
  • Be profecient in the use of databases and tools (Regulatory databases, Excel, Powerpoint, etc.).
 
skills: CMC, Chemistry
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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