job title:Associate II, Complex Gx, Regulatory Affairs(teva)

Roles and Responsibilities

• The Associate II, Complex Gx, Regulatory Affairs is responsible for the preparation and submission of high-quality regulatory filings—both pre- and post-approval—for U.S. FDA-regulated sterile complex generic products. With moderate to minimal guidance, the Associate II will manage regulatory submissions—including original applications, amendments, deficiency responses, and postapproval supplements—while collaborating closely with cross-functional teams. The role includes evaluating change controls, determining appropriate regulatory pathways (e.g., PAS, CBE-30, CBE-0, AR), confirming the change assessment with their regulatory manager, and submitting post-approval supplements in accordance with FDA guidelines and internal SOPs. The Associate II, on occasion, will also serve as a regulatory point of contact for assigned products and contribute to process improvement initiatives.

  How you’ll spend your day

  • With moderate to minimal guidance, prepare, review, and compile new submissions, deficiency responses (IRs, DRLs, CRLs), and amendments using the "Right-First Time" approach.

  • Work with their manager to support early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals.

  • Support regulatory assessments and decision-making for significant changes, including site transfers and alternate API sourcing.

  • On occasion, serve as regulatory contact point for cross-functional teams like R&D, QA, Manufacturing & Packaging sites, DMF holders, etc.

  • Monitor and manage regulatory timelines and proactively address data or document gaps.

  • Evaluate and classify change controls for regulatory impact and determine appropriate submission pathways.

  • Compile and submit post-approval changes (PAS, CBE-30, CBE-0, AR) ensuring compliance with FDA, ICH, and internal requirements.

  • Track regulatory guidance updates, stay current with evolving regulatory requirements.

  • Monitor relevant FDA databases (e.g., Drugs@FDA, Orange Book) and ensure internal stakeholders are informed of critical changes.

  • Participate in audits, inspections, and process improvement initiatives.

  Your experience and qualifications

  • Master’s degree in RA/QA discipline, preferably in Pharma.

  • Minimum 4+ years pharmaceutical industry experience with sterile products; Regulatory, Analytical, QA, laboratory or production experience preferred.

  • Demonstrates an understanding of ICH and FDA guidelines

  • Demonstrates excellent verbal and written communication skills.

  • Demonstrates excellent organization skills and the ability to multi-task; detail oriented.

  • Possesses strong critical and logical thinking.