This is a pharmaceutical company that is growing. It is a great place to work with good career advancement potential. They produce a wide range of pharmaceuticals with emphasis on pre-measured cups used in hospitals and nursing homes. It is a batch mixing , liquid filling operation.
Regulatory Affairs Manager
PRIMARY PURPOSE or JOB SUMMARY
The Regulatory Affairs Manager is responsible for management, planning and execution of Regulatory Affairs activities and developing CMC strategies across product life cycles. The incumbent will: ensure that all applicable FDA regulations and guidelines are considered and appropriately incorporated into development of new products as well as commercial product maintenance. Provide collaborative support for Regulatory department, Labeling and manage preparation of CMC-related submissions. Support for product development and commercial manufacturing operations providing regulatory support, guidance and expertise to internal groups such as product development teams, Quality, Manufacturing and Supply Chain.
- Develop regulatory and CMC strategy across product life cycles and manage regulatory activities/timelines for marketed products and/or investigational compounds, as assigned.
- Lead the preparation, writing, review and filing of regulatory submissions in an eCTD environment.
- Prepare/review/approve drug product and related information for routine periodic compliance-related submissions including Annual Reports, Safety Reports and Drug Listings.
- Participate in interactions with regulatory agencies such as FDA as required.
- Review and approve technical documentation including change controls, Annual Product Reviews, technology transfer protocols, process validation protocols/reports, method validation protocols/reports, technical reports, stability protocols/reports and specifications to assure conformance with regulations and regulatory guidelines.
- Provide regulatory guidance to project / product teams.
- Provide regulatory assessment of change controls, deviations, and GMP investigations.
- Maintain current knowledge of regulations and regulatory guidelines, particularly in US and EU.
- M.S. / Ph.D. in chemistry, biology or related pharmaceutical field preferred.
- Minimum of 8 years of experience in pharmaceutical product development/manufacturing including significant experience in Regulatory Affairs/Product Development/Quality with a strong small molecule and finished dosage form background or equivalent.
- Experience in working in a cGMP environment required. Experience in commercial drug product manufacturing environment is preferred.
- Experience in correspondence/interactions with regulatory authorities required.
- Knowledgeable in ICH and FDA guidelines relevant to CMC and/or Labeling aspects of product development and maintenance required.
- Ability to manage multiple complex projects, timelines and teams in a matrix team environment.
- Excellent analytical and communication skills - both verbal and written.
- Ability to communicate effectively to multiple levels of the organization with strong negotiation skills.
Knowledge and understanding of:
- Regulatory Affairs and Compliance Processes
- Pharmacovigilance obligations
- Quality Assurance
- Quality Management System
- Artwork management
- Supply Chain
- Understanding of Generic Pharmaceutical Business.
- Expertise in technology systems utilized for electronic documentation, including, but not limited to: Microsoft Office, Electronic Document Management System (EDMS)
- Expertise in technology systems utilized for the tracking of activities: Regulatory Tracking Database, BIBO environment, Trackwise or equivalent QMS systems
- Good presentation and training skills
- Good analytical and investigation skills
- Project management skills; excellent planning and organizational skills
- Technical writing for regulatory submissions
- Ability to prioritize based upon the compliance and patient safety risk
- Ability to identify critical issues and when they need to be escalated to senior management
- Accountable for the compliance of all activities in scope of responsibilities
- Strategic and results focused - ability to overcome obstacles and achieve key outcomes, ability to challenge the status quo in a constructive manner
- Integrity - overriding commitment to integrity and high standards in self and other
Regulatory Affairs / Regulatory Compliance