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Posted: Wednesday, December 13, 2017 12:16 AM

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Direct Sales Recruiting, LLC - Charlotte, NC

Pharmaceutical

Resumes: NancyC@directhr.com

Our client is a global leader in pharmaceutical solutions providing prescription products across multiple call points.

They are seeking to hire a Regulatory Affairs Director responsible for managing the creation and review of filings for new generic drugs and monitoring the activities and submissions of new products.

The role also manages the labeling process including the creation and implementation of labeling and the regulatory requirements associated ensuring compliance.

Responsibilities:

Monitor the creation, review, evaluation and submission of new drug filings/applications and reports in compliance of FDA submissions and drug filing regulations (U.S. & International)
Oversee Chemistry team; ensure projects are completed within deadline and respond to deficiencies

Manage post-marketing activities; Supplements submission, reporting, drug listing, etc.
Review product development reports and provide regulatory guidance
Maintain comprehensive electronic lists for deficiencies
Ensure prototype formulation compliance with Inactive Ingredient Database and provide CMC requirements guidance

Liaison for customs release inquiries and detained shipment releases
Review/update Standard Operating Procedures for CMC, labeling and filing
Create and review FDA submission documentation of SPL conversion of labeling
Monitor labeling filings, prepare new submissions and provide strategies
Manage label creation process/procedures; review and implement all labeling
Ensure company compliance and fulfillment of regulatory requirements in relation to labeling
Collaborate with regulatory agencies/groups for development of labeling

Requirements:
Bachelor’s Degree
Master’s Degree preferred
Min. 10+ years’ experience in Pharmaceutical Regulatory CMC and Labeling
Previous experience within generic pharmaceutical industry
Knowledge/Understanding of regulatory guidance, CFR, USP and ICH
Previous RA labeling experience strongly preferred
Knowledge/Understanding of drug development and post approval maintenance
Knowledge/Understanding of Chemistry batch records
Ability to prioritize & multi-task, ability to work collaboratively
Strong communication & project management skills
Advanced computers skills required

Offering:
Base Salary $120,000 - $150,000 (based on experience)
Bonus Potential
Full Benefits Package: matching 401K
Relocation Package available

Resumes to NancyC@directhr.com

Any information contained in this email is subject to change. Please review compensation package with the client at the appropriate time. Interviews are not an indication that an offer will be made.

All offers given by our clients are contingent on a thorough background check Direct Sales Recruiting, LLC, (DSR) and DirectHR are National Recruitment organizations partnering with National, Regional and Local Clients to bring qualified candidates a career and a future. DSR offers over 50 years combined Recruitment, Sales and Management experience.

We are, along with our clients, an Equal Opportunity Employer and are committed to hiring and supporting a diverse workforce.

• Location: Charlotte

• Post ID: 54021187 charlotte
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