Job Description

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 Senior Manager of Regulatory Affairs – Product Development and Post Approval serves as the primary regulatory interface with FDA, Partners and internal team.   Ensure the business needs for the assigned products are met by anticipating, identify, prioritizing and mitigating regulatory risks while ensuring compliance with all regulatory requirements.  Develops and oversees the regulatory strategy, preparation and review of FDA Submissions including Amendments, Supplements, Annual Reports, DMF updates and labeling changes. Ability to make decisions that may have implications on the strategy, management and operations of an area within a department.  Additional key areas of role focus involve: 

• Administering of the Change Control Process
• Draft, review, approve, and submit supplements, amendments, annual reports, field alert reports to the FDA and/or to partners
• Review and approval of advertising and promotional materials
• Review and approval of Annual Product Review reports
• Develop curriculum and mitigate workload for direct reports and develop a plan for success and advancement for direct reports.
• Point of contact for CMO and internal departments
• Assist with ANDA submissions

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

• Accurate interpretation and implementation of the regulatory requirements leading to the highest quality regulatory submissions
• Ensuring the quickest possible launch of new products
• FDA accepted / granted supplements and submission approvals
• Timely review and assessment of change controls
• Effective and efficient electronic submissions
• Maintain current knowledge of regulations

Key Duties & Responsibilities: 

• Develop regulatory strategies and implementation plans for the preparation and submission of new products (ANDA/NDA’s)
• Provide guidance on regulatory requirements to departments or development project teams 
• Direct the preparation and submission of product development correspondences to the FDA 
• Interfaces with agencies in order to obtain timely approval to produce and market new products
• Involved in all aspects of post-market regulatory affairs including but not limited to post approval change control assessments and supplement submissions. Develops regulatory strategies, prepares and reviews submission packages for FDA submission including Amendments, Supplements, Annual Reports and DMF’s in line with regulatory requirements, regulatory guidelines, and GMP compliance.  Determines and approves data requirements, regulatory reporting categories, and gathers, assembles and reviews documentation and data from partners as needed to support submissions. Reviews, administers and approves change control process by reviewing proposed changes against most recent applicable filings to ensure regulations, guidelines, and commitments are satisfied.
• Management and/or training of Regulatory Affairs staff (Not all individuals in this position have this)
• Management of specific regulatory affairs programs and systems which may include: field alert reporting, management of contract manufacturers and partners, procedures and process including training staff to ensure effective and efficient electronic submissions.

Knowledge or Experience: 

• Solid knowledge of regulatory pharmaceutical drug development process and life cycle management including strong command of CGMP’s/FDA regulations, Quality systems, FDA Guideline documents, USP, ICH and other applicable laws. 
• Pharmaceutical drug and/or device development and/or manufacturing experience; sterile injectable experience highly preferred.
• 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.
• Strong interpersonal skills, effective written and verbal communication, problem solving and decision-making skills and ability to interact with all levels of management.
• Experience successfully negotiating directly with the FDA, partners and internal teams.
• Ability to lead, mentor, and develop others for future growth and development.
• 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.
• Author and sign eCTD section templates, End-User Letters to the FDA for import, and internal memos or certificates (Debarment, BSE/TSE, etc.)

Minimum Qualifications / Experience: 

• 5 or more years of regulatory affairs experience.  Post Approval Preferred
• 5 or more years of experience in managing, developing, and maintaining department wide, mission critical, scientific or regulatory projects preferred. 
• Regulatory publication eCTD software experience preferred.

Education / Certifications: 

BS in Pharmacy, Microbiology, Toxicology, Chemistry, Pharmacology or related Life Sciences degree required. Advanced degree preferred. Will consider BA/BS degree in life sciences or a health related field. 

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.