Regulatory Manager

Sterling-Hoffman Executive Search Located in: Delaware
(Private and Secure - Guaranteed!)

Sterling-Hoffman Executive Search Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

Our client is currently seeking a driven and ambitious Regulatory Manager to join their team. This is a unique opportunity for a highly motivated professional who has a go-getter attitude.

1) Manage regulatory affairs drug product development projects through entire lifecycle - from initiation through commercialization
2) Manage the Regulatory Department and develop processes so that new chemical entities, new dosage forms and new indications are registered in a timely fashion
3) Ensure that all state and federal regulatory requirements are addressed for the clinical research program and for marketed products
4) Develop professional relationships with TGA staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations
5) Provide regulatory expertise to clinical project teams
6) Conduct training sessions for CRAs and sales representatives on ADR reporting
7) Develop and track regulatory project timelines that incorporate all submission requirements including CMC, clinical and labeling functions
8) Communicate regulatory requirements and expectations to various contract organizations, including travel for on-site meetings as necessary
9) Contact FDA and other regulatory authorities for review status updates for pending applications and supplements
10) Evaluate proposed changes to approved products for potential regulatory impact

CRITICAL REQUIREMENTS

  • 1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
    2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    3) Recent experience in the pharmaceutical industry is strongly preferred
    4) Preference will be given to people have recent experience in regulatory management

    If you imagine yourself working for an excellent company whose employees believe in team work and making great contributions to the industry, this could be a golden opportunity for you.

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION

Seniority Level:
Management / Supervisory
Function:
  Regulatory Affairs
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation:
A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.