CMC Regulatory Affairs Director

The Staffing Resource Group, Inc
Published
July 21, 2021
Location
Atlanta, GA
Category
Job Type

Description

CMC Regulatory Affairs Director


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 Director

Location: Richmond, VA (possible remote for the right candidate)

Industry: Pharmaceutical

Hours: Mon-Fri 8AM - 5PM

Salary: Competitive 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 or contract (may consider contract for the right candidate)

Environment: Join a growing 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.

Overview:

The Director, CMC Drug Regulatory Affairs plays a pivotal role in the development, licensure, manufacturing, and ongoing marketing of our pharmaceutical products. Reporting to the EVP of Regulatory Affairs, this individual will have responsibility for providing CMC regulatory leadership and strategy required to achieve regulatory approvals, collaborating closely with multiple scientific, technical, quality, and commercial areas within the company and with external contract manufacturing organizations (CMOs). This position provides knowledge, understanding, interpretation, and utilization of regulatory guidances and regulations, as well as industry and government agency best practices and trends.

Responsibilities:

Lead, develop, and implement CMC regulatory strategies to ensure on-time and high-quality submissions for Drug Master Files (DMFs), marketing applications (NDA/ANDA), and post-approval lifecycle submissions.

Perform critical review of all CMC documentation supporting regulatory applications, to ensure compliance with regulatory requirements and to effectively present data and strategy to regulatory agencies.

Provide regulatory risk assessment for submissions, identify key risks to one-cycle review and approval. Develop mitigation and/or proactive response strategies.

In concert with Regulatory Operations, ensure completeness and timeliness of eCTD submissions.

Develop regulatory strategy and execute in the preparation of timely responses to CMC regulatory questions, pre-meeting packages, and interactions with Heath Authorities.

Manage products and change control in compliance with regulations and company policies and procedures. Assess proposed manufacturing changes and provide regulatory guidance to enable regulatory and filing implementation.

Lead or contribute to development of internal regulatory procedures and working instructions.

Ensure proper CMC regulatory assessments and actions are taken for Field Alert Reports, or when product complaints arise during product lifecycle.

Serve as a CMC Regulatory Subject Matter Expert, maintaining broad and deep knowledge of current and emerging regulatory requirements, e.g., FDA, ICH, EU. Analyze legislation, regulation, and guidance to provide awareness and impact assessment for the organization.

Qualifications:

Experience developing and implementing successful CMC regulatory strategies

Extensive regulatory experience for both development projects and commercial products, with evidence of successful submissions to FDA, e.g., DMF, NDA, ANDA.

Strong experience with CTD format and content for regulatory filings

Strong knowledge of eCTD elements and structure

Exceptional oral and written communication skills, including regulatory technical writing skills.

Experience working with all levels of management and key business stakeholders.

Strong knowledge of drug development, and Current Good Manufacturing Practices (CGMP), as well as FDA, ICH, EU regulations and guidelines

Ability to work in a cross-functional team environment with dynamic timelines and priorities

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