Sr. Associate, Regulatory Affairs Sagent Pharmaceuticals
Sr Manager, Regulatory Affairs AND/OR Associate Director Regulatory Affairs
Job Summary / Overview:
The role is primarily responsible for the management and support of Pre and Post approval regulatory activities supporting new product filings to the FDA including annual registration maintenance and foreign registrations.
Success in the role is measured on:
- Timely and accurate annual report filings, supplements or ANDA submissions as per FDA regulation guidelines.
- No reworks, delays in launch or commercial availability or quality/regulatory impacts (recalls, etc.)
Key Duties & Responsibilities:
- 50% - Prepare documentation needed to maintain registration of products. Manage the annual report submissions, DMF updates and labeling changes. Assemble, review and submit product annual reports within the regulatory time frame.
- 30%- Manage and support product post-approval regulatory activities. Review and approve change controls, submit post approval changes and supplements as agreed with partners and as needed to support regular manufacture and distribution of Sagent?s products. Coordinate efforts to answer deficiency letters, establish regulatory strategies, and advise on regulatory strategies and data requirements.
- 10%- Submit original ANDA for FDA review. Submit Amendments or other 505(b)(2), DMF?s and 510(k)?s submissions in support of filings owned by Sagent or where Sagent as the U.S. Agent. Identify, assist with gathering, and evaluate data from partners as needed to support all submissions.
- 10%- Support Foreign Registration: Create ANDA Dossier, prepare, review and submit packages for CPP Request
- 10-20% domestic and international travel required.
Knowledge or Experience:
- Strong knowledge of FDA submission regulations and guidelines
- Knowledge of cGMP and ICH Guidelines
- Experience with Regulatory planning and organization
- Proficient with PC-Based word processing software, databases and spreadsheets
Minimum Qualifications / Experience:
- 2 to 5 years of direct pharmaceutical industry experience OR solid equivalent experience in cGMP environment (manufacturing preferred) OR Regulatory Affairs (RA preferred).
- Broad career progression including experience in multiple departments in pharmaceutical, drug development and/or manufacturing industry preferred.
- Injectable product experience is a plus.
- Strong planning and organizational / project / workload management skills
- Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects
- Ability to prioritize projects independently as well as experience working in project teams
- Ability to drive projects to completion with minimal oversight.
- Solid interpersonal (verbal and written) communication skills at all levels.
- Drive, Motivation and Initiative to troubleshoot and problem solve; Solid critical thinking / analytical skills
- Formal project management skills a plus
- Flexibility and strong negotiation skills
- Thrive in, and be able to work in, a fast paced entrepreneurial environment with broad responsibilities
- Have a passion for quality and an impeccable detail orientation
Education / Certifications:
- Bachelor?s degree required. Science background degree preferred (Chemistry, microbiology/biology, pharmacy, premed, nursing).
||1901 North Roselle Road |
Schaumburg, IL 60195