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Job Details

Manager, Regulatory Affairs

Company: RBW Consulting
Location: Piscataway, New Jersey
Reference: RAA-MRA-PNJ
Closing Date: 21 May 17
Type: Full Time
Salary (£): 100,000+
Benefits: Competitive Benefits Package

Job Summary:

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Requirements:

Manager, Regulatory Affairs 
Piscataway, NJ

The manager, regulatory affairs is a critical role within the regulatory affairs, CMC organization who has responsibility in the development and review of ANDA submissions to the FDA. Additionally, the manager regulatory affairs provides support to various stakeholders regarding regulatory strategies for assigned projects. The role may also supervisor subordinates.

Compile, prepare, critically review and submit ANDA submissions and Amendments to FDA with an overall objective to receive approval within the shortest time frames possible. 

  • Ensure timely submission of all assigned projects.
  • Ensure final ANDA meets the requirement of latest ANDA checklist recommended by USFDA to avoid any acceptance to file issue.
  • Responsible for all Change Control evaluations and to develop regulatory post approval filing strategies ( pre and post approval)
  • Compile and submits post-approval supplements, such as CBE, CBE-30 and PAS
  • Submit controlled correspondence to FDA on specific issues as needed for assigned projects.
  • Evaluate final compositions for IIG and Proportionality similar criteria’s and develop regulatory strategies to avoid acceptable for filing issues.

Responsible for regulatory strategies for all assigned projects covering all key points. 

  • Support product development and analytical development teams to provide right regulatory strategies as and when needed.
  • Work very closely with all relevant departments at the time of product initiations, R&D phase, ANDA/Bio Execution and after initiation of stability to ensure timely availability of all documents to ensure timely submissions.
  • Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.
  • Arrange meeting with all stakeholders’ immediately after receipt of deficiency letter from FDA and finalize the regulatory strategy to respond to the deficiencies letter(s).
  • Proactively raises major project issues to superior for resolution and agreement.
  • Manages the regulatory associates in the preparation, compilation of “High Quality Submissions” to FDA.
  • Ensure that labelling complies with all federal, state and local requirements/regulations and component format conforms to specifications to assure optimal functionality. Responsible to Proofread and approve all product labelling components. 
  • Monitor impact of changing regulations on submission strategies and update internal stakeholders accordingly. 
  • Review the DMFs thoroughly and share the review comments to purchase department on-time. Follow up with purchase team or with DMF holder directly as needed to ensure compliance to provided comments on-time. 


Desired Job Experience 

  • 7 Years or More exp. is required in RA and formulation/Analytical Development
  • Master Degree, Science, Technical 

Other Qualifications 

  • Communicate with consultants, attorneys and external parties as needed to obtain scientific data for submissions
  • Review and approve Annual Reports.
  • Review/Approve the Change Controls and Deviation related to RA decision tree.

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Apply for this job: Manager, Regulatory Affairs

Contact Information:

Address:  US Team
210 Broadway #201, Cambridge, Massachusetts,
02139
USA
Tel:  (617) 982 1238
Website:  Visit Our Web Site

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