Manager, Regulatory Affairs -Product Development & Post Approval

Sagent Pharmaceuticals - Schaumburg, IL

Manager, Regulatory Affairs - Product Development and Post Approval

Sagent Pharmaceuticals, founded in 2006, was built to focus on customer needs. At Sagent, we believe that excellence is our standard, our motivation and our guide. We believe the measure of success is determined by our customers, as we are a customer-focused company, delivering an extensive portfolio of injectable products and fulfilling the evolving needs of the patients we serve through our unique network of global resources.

The Manager of Regulatory Affairs - Product Development and Post Approval serves as the primary regulatory interface with Partners and internal teams regarding Drug Product and Analytical method development and post-approval activities. They ensure the business needs for the assigned development and post-approval of products are met by anticipating, identifying, prioritizing, and mitigating regulatory risks while ensuring compliance with all regulatory requirements.

They develop and oversee the overall regulatory strategy, preparation, and review of regulatory documentation for ANDA's and NDA's. They will make decisions that may have implications on the strategy, management, and operations of an area within a department.

Communicates directly with FDA Reviewers on status and questions related to FDA submissions.

Post-approval regulatory activities include compilation/review of Annual Reports, Advertising/Promotional material, and product labeling, as well as assessment of proposed changes to manufacturing facilities, processes, and controlled documents.

Success for this role would be measured primarily by the following:

• Provide in-depth and timely Drug Product and Analytical development and regulatory strategy/input for all new development projects and in-licensing projects.
• Accurate interpretation and implementation of the regulatory requirements leading to the highest quality regulatory submissions.
• Preparation, editing, and/or review to facilitate high quality and accurate submissions for original applications and amendments to secure timely application approvals.
• Reductions in time to market as a result of continuous operational improvement initiatives.
• Effective communication with all levels of staff across all departments and development partners
• Develop, apply, and report on development and regulatory metrics.
• Timely and accurate pre-submission review and electronic filing of FDA submissions including ANDA's, 505(b)(2)s, Amendments, Supplements, Annual Reports, DMF updates, labeling changes, and Advertising/Promotional material.
• Timely and accurate review of change controls according to regulatory guidelines.

Key Duties & Responsibilities:

Product Development

• Involved in all aspects of Drug Product and Analytical development working with regulatory affairs from outlining the data requirements for new original applications.
• Develops strategies, prepares and reviews dossiers for FDA submission including NDAs, BLAs, ANDAs, INDs, Amendments, Supplements, and DMFs in line with regulatory requirements, regulatory guidelines, and GMP compliance.
• Serve as SME for Product Development, Project Management, Marketing, Sales, Business Development, teams and partners as needed.
• Ensure the business needs for the assigned products are met by anticipating, identifying, prioritizing, and mitigating regulatory risks while ensuring compliance with all regulatory requirements.
• Management of specific development programs and systems which may include:
• Management of the assigned projects and program.
• Manage quality systems related to Regulatory Affairs including performance management metrics, standard operating procedures, documentation storage, project management tool development, and management of programs for regulatory tracking.

Post Approval

• Post-approval product support activities: Compilation and review of FDA Submissions (e.g., Supplements, Annual Reports, DMF Updates, labeling packages) as agreed upon with partners; and change control review/approval.
• Coordinate compilation/review of Advertising/Promotional material with Marketing for Manager's review and approval. Submit Advertising/Promotional materials to FDA's OPDP via electronic methods.
• Domestic and international travel may be required.

Knowledge or Experience:

• Solid knowledge of all aspects of development related to the pharmaceutical drug development process and life cycle management including strong command of FDA regulations, FDA Guideline documents, USP, ICH, and other applicable laws.
• Direct experience in preparing submissions in the required CTD format and electronic submissions to the FDA and other health authorities, as required.
• Able to clearly articulate regulatory strategy at partner and project management meetings. Able to negotiate with partners to assure acceptance of regulatory strategy. Assures compliance with project team timelines and milestones.
• Analytical and pharmaceutical drug product development knowledge and understanding of various dosage forms, parenteral dosage forms preferred.
• Experience in product due diligence for new development projects and in-licensing projects
• Experience in the use of PC-based word processing software, databases, spreadsheets, and Adobe Acrobat, including database management and support.
• Experience with metrics management and reporting.
• Proficient in the use and preparation of electronic regulatory submissions under FDA and ICH Common Technical Document (CTD) XML-compliant schema is preferred.
• Strong interpersonal skills, effective written and verbal communication, problem-solving, and decision-making skills, and ability to interact with all levels of management.
• Experience in successfully assisting in negotiations with the FDA, partners, and internal teams.
• Effectively prioritize workload and manage time to complete multiple projects within established timelines and goals with minimal supervision in a fast-paced environment.
• Ability to work in a cross-functional team environment and a flexible team-oriented perspective.

Minimum Qualifications / Experience:

• 3-5 years of pharmaceutical development experience, focusing on parenteral dosage forms with emphasis on product development, product due diligence, regulatory strategy for new products, and FDA communication.
• Direct experience in preparing CTD format and electronic ANDA submissions to the FDA required.
• 2 or more years of direct pharmaceutical industry experience OR equivalent experience working in a cGMP and/or FDA regulated environment is preferred.
• Regulatory publication eCTD software experience preferred.

Education / Certifications:

BS / Pharm D in Pharmacy, Biology, Chemistry, and Microbiology required. Advanced degree preferred.

Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.