Job Details  
Advertiser: First People Solutions

 
Job Title: Cmc Regulatory Affairs Manager
Location:Dublin
Rate:£0 Per Year
Description: Are you an experienced CMC Regulatory Affairs Manager within the Pharmaceutical industry? This position is based in County Dublin.

This is a great chance for you to work in an exciting team whilst gaining valuable experience within a highly regulated environment. You would be working with a fantastic global Pharmaceutical company based in County Dublin. They’re looking for a CMC Regulatory Affairs Manager and the rate is negotiable depending on experience. It is a on an initial 12 month contract role that does offer high opportunity of progression.

As a CMC Regulatory Affairs Manager you will be responsible for

Job Description:

* Serving as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
* Manage regulatory issues, maintain submission information in relevant GCMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
* Ability to present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment, provide consultation as a scientific/technical resource for assigned projects, mentor and share experience with colleagues.
* Authors and/or coordinates clinical, post approval, renewal and line extensions to meet filing requirements for regulatory CMC submissions. Coordinates & contributes to responses to Agency queries and performs quality review of regulatory CMC submissions.
* Serves as a technical and scientific resource within own work group/discipline and provides guidance for completion of difficult and complex projects.
* Prioritize & independently complete assigned workload appropriately.
* Developing effective relationships with local & global internal partners, i.e., R&D (PTx, BTx, PCH), PGS, WSR, BU’s, etc.,
* Developing relationships with regulatory authorities to improve Pfizer’s regulatory success
* Demonstrate & model adherence to all behaviours & values, embrace & comply with GCMC Principles of Integrity.

Required Skills:

* Bachelor’s degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline with 6+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 3+ years pharmaceutical regulatory experience.
* Minimum of 2+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.
* Advanced skills in written & oral communications are mandatory.
* Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.
* Prior experience managing projects is preferred.


If you’re interested then apply today!
Skills Required: CMC, Chemistry Manufacturing and controls, Regulatory Affairs Manager
Job Type: Contract
Start Date:
Contact: Alana Bittles Contact E-mail: Click
Contact Tel: 0141 270 5006 Contact Fax:
Reference: 4241 Added: 16-12-2017
  IMPORTANT: For jobs based in the UK it is unlawful to employ a person who does not have permission to live and work in the UK. Please ensure you have this permission before applying, unless the advert states otherwise.
 
 
 
 
 
 
 
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