Manager, CMC Regulatory Submissions III in Lexington, MA at APEX Systems

Date Posted: 12/4/2019

Job Snapshot

  • Employee Type:
    Contractor
  • Location:
    Lexington, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    12/4/2019

Job Description

Job #:  1030466
Apex Systems combines with parent company On Assignment to make it the 2nd largest IT staffing agency in the country.
Apex has an opportunity for a Manager of Regulatory Submissions role in Lexington, MA. This is a 12+ month position and the pay rate is flexible depending on experience. Here are the details: 
 For applicants who are interested in the Manager of Regulatory Submissions Opportunity; please send a Word resume to John Lobdell, Technical Recruiter, at jlobdell@apexsystems.com
 Position: Manager of Regulatory Submissions
Apex Job ID: 1030466
Location: Lexington, MA
Rate: Negotiable based upon experience
Duration: 12+ months
Position Description:
Under the direction of the Submissions line manager, the Submissions Lead is responsible for execution of global Regulatory Submissions operational activities in support of pipeline programs, Marketing Applications and Agency request for information, Post- Approval changes, etc. The manager will be tasked with establishing global submission activities and timelines in partnership with global and cross functional stakeholders across a variety of departments within the business.
 
Responsibilities:
  • Planning and tracking for submission activities for the assigned product/project, ensuring appropriate stakeholder engagement and participation
  • Support operational excellence for regulatory submissions by adhering to and applying established processes and tools
  •  Day-to-day management of regulatory submissions, including preparation for and leading of meetings, document manipulation and routing for authoring and review, etc.
  • Provide guidance for submission granularity and global submission requirements.
  • Enable high quality documents through content review and compliance to submission ready standards
  • Develop and maintains strong communication and collaboration with the stakeholders.

Qualifications:
  • Bachelor’s degree or advanced degree in Chemistry, Pharmacy, or closely related field is highly desirable.
  • Minimum 5 years’ experience in the Pharmaceutical Industry or relevant Regulatory environment including experience in regulatory submission management
  • Familiarity with pharmaceutical product/process development, regulatory guidelines and experience in regulatory submissions throughout the development lifecycle desired.
  • Solid working knowledge of current GMP guidelines and regulatory requirements.
  • Knowledge of drug development for drug substance and drug product.
  • Project Management skills.
  • Strong knowledge of Windows environment and Windows-based desktop productivity applications including Word, Excel, Adobe Acrobat and MS Project. Electronic Document Management as well as advanced Microsoft Word capabilities is preferred.

 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.