- Title: Regulatory Affairs Specialist III
- Code: RCI-03050
- Location: Bridgewater New Jersey (NJ) 08807
- Posted Date: 10/05/2020
- Duration: 6 Months
- Name:Ankit Shah
- Email: Ankit.Shah@rangam.com
- Phone: 908-704-8843 ✖ 210
Job Title: CMC Small Molecule Marketed Contractor as Individual Contributor
Responsible for assisting in the post-approval maintenance of products within the portfolio of Regulatory CMC Small Molecule Marketed function.
• 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
Knowledge, Skills & Competencies / Language:
- 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.).
- 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.