18 days old

Manager/Senior Manager, Regulatory Affairs

Verastem Oncology
Needham, Massachusetts 02494
  • Job Type
    Employee
  • Job Status
    Full Time
Company Profile:
 
At Verastem Oncology we care differently and because of this we hire differently. We look for people who share our perspective; when others see only a problem, we see an opportunity, when others give up, we step up. Our team has the drive and capacity to embrace rapid growth, celebrate achievements and then quickly return focus to work, because our patients are counting on us.  Our mission is to discover and develop drugs to improve outcomes for patients with cancer. This commitment is central to who we are as a company and the culture we nurture. We appreciate your candidacy for the Verastem Oncology team, and encourage you to learn more about how we care differently at www.verastem.com
 
Summary:
 
The Manager/Senior Manager Regulatory Affairs is responsible for assisting in the preparation and submission of INDs, IMPDs, NDAs,  amendments, and other regulatory submissions as required in collaboration with appropriate leadership.
 
Responsibilities:
 
  • This position requires familiarity with U.S. Federal Regulations related to clinical research (21 CFR Parts 50, 56, 312), ICH guidelines, and a familiarity with GLP and GMP requirements and guidelines (21 CFR 58, 210 and 211).  It also requires:
  • Assistance in preparation and submission management of INDs, IMPDs, NDAs, amendments and other regulatory submissions, as required.  Coordinate with Clinical Research, Clinical Operations, Manufacturing and other groups to ensure timely and accurate preparation of regulatory submissions.
  • Ensures accuracy and submission management of regulatory documentation according to established timeframes.
  • Coordination with team members, in the preparation and submission management for Advertising and Promotion 2253/Pre-submission filings.
  • The ability to set up and maintain regulatory files and submission archives to ensure proper storage and retrieval of regulatory documentation.
  • Preparation and maintenance of regulatory submission trackers and notification to and coordination with team members for upcoming submissions.
  • Excellent communication skills, both verbal and written, including appropriate use of medical and scientific terminology.
  • Excellent interpersonal skills.
  • The ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events.
  • Assist in the preparation and review of timely draft and final reports, as appropriate.
  • Prepare and review standard operating procedures and policies, as appropriate.
  • Develop and maintain a working knowledge in the specific areas related to GCP, GLP and GMP compliance including, but not limited to regulatory and ICH requirements.
  • Assist senior staff during regulatory inspections.
  • Other duties, as required.

Requirements

Qualifications:

  • BA/BS in a scientific discipline.
  • Minimum of 6 plus years of Regulatory Affairs experience in the biopharmaceutical area, or equivalent is required.
  • A broad understanding of the drug development process is required. 
  • A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments. 
  • Good interpersonal skills with knowledge of basic negotiation, influencing and conflict management to ensure effective interactions within and across departments.

Categories

Posted: 2020-02-03 Expires: 2020-03-04

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Manager/Senior Manager, Regulatory Affairs

Verastem Oncology
Needham, Massachusetts 02494

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