Senior Manager, Regulatory Affairs Sagent Pharmaceuticals
Sr. Director, Regulatory Affairs
Job Summary / Overview:
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 NDA?s, ANDA?s, 510k?s, PMAs, 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
- Review and comment on development documentation including validation protocols, batch records and development protocols.
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 approval and launch of new products.
- FDA accepted / granted supplements and submission approvals.
- Timely product development
Key Duties & Responsibilities:
- 80% - Involved in all aspects of regulatory affairs from outlining the data requirements for new original applications and submissions to post approval changes approval and supplementation.
Develops regulatory strategies, prepares and reviews dossiers for FDA submission including NDAs, ANDA?s, Amendments, Supplements, Annual Reports, DMF?s, 510(k)?s and PMAs 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.
- 10% - Management and training of Regulatory Affairs staff.
- 10% - Management of specific regulatory affairs programs and systems.
Knowledge or Expertise:
- Solid knowledge of all aspects 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.
Minimum Qualifications / Experience:
- 5 or more years experience in research and development of new pharmaceutical products.
- 5 or more years of regulatory affairs experience, global regulatory affairs experience preferred.
- 3 or more years of Adverse Events management experience.
- 5 or more experience in managing, developing, and maintaining department wide, mission critical, scientific or regulatory computer systems preferred. Software validation experience preferred.
- 3 or more years experience supervising staff. Experience supervising pharmaceutical drug development staff strongly preferred.
- Regulatory publication eCTD software experience preferred.
- Docubridge publication software experience preferred.
Education / Certifications:
BS or MS in Chemistry, Microbiology, Toxicology or Pharmacology.
||1901 North Roselle Road |
Schaumburg, IL 60195