LGM Pharma has an open position for a Senior Regulatory Affairs Specialist based in the Irvine, CA location.

RESPONSIBILITIES:

Planning:

• Oversee ANDA/NDA submission and approval process for regulatory.
• Collaborate in company Standard Operating Procedures (SOP's) development and review.

• Develop and assesses strategies for regulatory approvals for NDAs and ANDAs by providing input for product development through commercialization.

Pre-Market:

• Reviews documents for regulatory compliance necessary for the acceptability of quality documentation for submission filing.
• Develop pre-approval compliance activities during manufacturing submission batches.

• Perform label development and reviews for compliance.
• Monitor impact of changing regulations on submissions and provides recommendations for implementation.
• Ensures applicable reports to regulatory authorities are submitted on time as required.

Post-Market:

• Maintains annual licenses, registrations, listings and patent information as required.
• Prepare annual reports for NDA/ANDAs by scheduling and coordinating receipt of documentation/information, preparing cover pages describing changes made to an application and tracking progress of their preparation.
• Review of documents and interacting with multiple departments (QA, Manufacturing, Project Management, Engineering, PD, etc.) which provide information and documentation utilizing the change control database to ensure accurate reporting to FDA.
• Maintaining approved NDA/ANDAs current by requesting revisions to technical documentation as part of the annual report preparation process.
• Provide a critical detailed review of technical documentation including labeling, distribution reports, analytical procedures, product specifications, manufacturing and packaging batch records, in-process specifications, etc. prior to FDA submission.
• Interacts with representatives from the Food and Drug Administration (FDA), Notified Body, Authorized Representative and other regulatory agencies, to resolve issues or questions in the application.
• Prepare, revision and approval of labeling.
• Participate in the preparation and submission of required post approval reports such as field alert reports, periodic adverse drug experience reports etc. Ensures product safety issues and product-associated events are reported to regulatory agencies.
• Ensures compliance with product post-marketing approval requirements, annual reports, drug listings, labeling, pharmacopeia changes (pre and post approval), etc.
• Reviews regulatory aspects of contracts with customers.
• Provides regulatory support for product recalls and recalls communications.

• Other related duties as required.

QUALIFICATIONS:

• Bachelor's degree in science (biology, chemistry, microbiology, and pharmacy).
• 10+ years' of experience in a regulatory function within pharmaceuticals (preferred) or medical products; experience in quality assurance and/or compliance may be considered.
• Certification such as RAC from the Regulatory Affairs Professionals Society preferred.
• Experience with electronic regulatory submissions.
• Knowledge of USP, and Code of Federal Regulations 21 CFR 111, 11, 210, and 211. FDA/ICH guidance and the regulatory process pertaining to drug development and approval.
• Strong interpersonal skills and ability to handle multiple high priority assignments with discretion
• Strong technical writing skills and acute attention to detail.

• Strong knowledge and understanding of CMC.
• Ability to read and interpret complex technical documents. Ability to write comprehensive reports.
• Strong communication skills, both written and verbal.

• Able to build rapport at all levels of the organization as well as with external contacts.
• Proficient in MS Office suite of products (Word, Excel, Powerpoint, etc.)

At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer. We offer medical, dental, vision and company matching 401K. All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.