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Regulatory Affairs Manager at The Staffing Resource Group, Inc

Regulatory Affairs Manager

The Staffing Resource Group, Inc Richmond, VA Full-Time
$100,000.00 - $120,000.00 / year
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CMC Regulatory Affairs Manager

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Title: CMC Regulatory Affairs Manager

Location: Williamsburg, VA 

Industry: Pharmaceutical

Hours: Mon-Fri 8AM - 5PM

Salary: Generous compensation. If direct hire, one’s medical benefits (including family) is 100% covered, up to 30% target bonus (individual and company performance), stock options and 30 days PTO.

Employment Type: Direct hire

Environment: Join a start-up pharmaceutical manufacturing company dedicated to providing high-quality, low-cost pharmaceuticals through state-of-the-art, U.S. based advanced manufacturing processes. The company will manufacture precursor chemical ingredients, active pharmaceutical ingredients (API), and finished pharmaceutical products, domestically for essential medicines critical to the ones’ healthcare. To help ensure the quality, safety, and affordability of pharmaceutical products of strategic importance to the United States this client utilizes advanced manufacturing platforms, including continuous manufacturing, to provide essential medicines to its customers, health systems, and government partners.



Overview:

The CMC Regulatory Affairs Manager is responsible for planning, managing and tracking regulatory documentation, and successful preparation and filing of submissions (DMF, ANDA, NDA) in the required electronic format. This role serves as the system owner for regulatory information tools and technologies, and develops processes to ensure submission are complete and comply with applicable regulatory requirements, in a fast-paced environment. This individual collaborates with cross-functional teams (RA, QA, IT, etc.)

Responsibilities:

Working closely with the Quality, Manufacturing and Development teams to track deliverables for preparation of regulatory submissions and other correspondence with FDA. Update management regarding status of deliverables and identify critical activities/risks for timeline.

Contributing to the creation and implementation of development and post-approval regulatory strategies for assigned projects and programs.

Managing vendors in support of electronic publishing and other aspects of regulatory operations

Managing establishment registrations and drug listing requirements in compliance with FDA requirements, manage payment of establishment registration fees, and other fees (e.g.,GDUFA) associated with regulatory filings

Providing operational support as required for internal audits, FDA audits and FDA CGMP/GLP inspections

Contributing to the planning, preparation and review of regulatory authority submission documents, and ensure the submissions are complete and comply with applicable regulatory requirements.

Assisting with imports, ensuring necessary documentation is provided for FDA clearance at Port of Entry

Assisting in tracking regulatory commitments and change control activities to ensure manufacturing changes are reported to authorities in accordance with regulatory requirements

Managing preparation of Annual Reports to FDA in compliance with obligations of the application holder

Maintaining up-to-date knowledge of global standards and procedures for regulatory submissions, including FDA ESG, eCTD, IDMP, and ensure standards and procedures are compliant with these requirements.


Responsibilities:

 Working closely with the Quality, Manufacturing and Development teams to track deliverables for preparation of regulatory submissions and other correspondence with FDA. Update management regarding status of deliverables and identify critical activities/risks for timeline.

 Contributing to the creation and implementation of development and post-approval regulatory strategies for assigned projects and programs.

 Managing vendors in support of electronic publishing and other aspects of regulatory operations

 Managing establishment registrations and drug listing requirements in compliance with FDA requirements, manage payment of establishment registration fees, and other fees (e.g.,GDUFA) associated with regulatory filings

 Providing operational support as required for internal audits, FDA audits and FDA CGMP/GLP inspections

 Contributing to the planning, preparation and review of regulatory authority submission documents, and ensure the submissions are complete and comply with applicable regulatory requirements.

 Assisting with imports, ensuring necessary documentation is provided for FDA clearance at Port of Entry

 Assisting in tracking regulatory commitments and change control activities to ensure manufacturing changes are reported to authorities in accordance with regulatory requirements

 Managing preparation of Annual Reports to FDA in compliance with obligations of the application holder

 Maintaining up-to-date knowledge of global standards and procedures for regulatory submissions, including FDA ESG, eCTD, IDMP, and ensure standards and procedures are compliant with these requirements.

Qualifications:

 Minimum 5 or more years of pharmaceutical industry experience with a focus on regulatory submissions experience. Work experience must include U.S. submissions to FDA of chemistry, manufacturing and controls (CMC) information. EU experience is desired, but not required.

 Experience with Regulatory submission processes from document authoring and management, submission publishing, to regulatory information management and archive

 Experience with Drug Master File (DMF), ANDA and NDA submissions, implementing EDMS applications, eCTD submission requirements and ESG

 Experience with sterile injectables within cGMP environment

 Must be proficient in MS Sharepoint, MS Office 360 (MS Word, MS Excel, MS Powerpoint), Adobe Acrobat Pro.

 Demonstrated entrepreneurial abilities, organizational skills, strong verbal and written communication skills, attention to detail and can work with all levels of personnel

 Bachelor’s Degree in relevant discipline, with scientific discipline. Masters’ Degree highly preferred, but not required

EOE/ADA

Recommended skills

Anda
Ectd
Nda
Regulatory Filings
Regulatory Legislation And Guidelines
Regulatory Submissions
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