Assoc Dir Regulatory Affairs

Bangalore, Karnataka
Permanent
Full-time

29 days ago

Who we areTogether, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.The opportunityThe Associate Director, Complex Gx, Regulatory Affairs serves as a strategic regulatory leader, responsible for independently guiding and executing all regulatory activities-both pre- and post-approval-for U.S. FDA-regulated semi-solid, transdermal, and nasal spray complex generic products. This role ensures regulatory compliance, drives operational excellence, and leads a team of regulatory professionals to deliver high-quality submissions and lifecycle management initiatives. The Associate Director acts as a key liaison with the FDA, internal cross-functional teams, and external partners. This role will also facilitate strategic alignment with FDA through early and proactive engagement during product development, enabling streamlined development pathways, mitigating regulatory risk, and accelerating time-to-market-ultimately increasing the likelihood of first-cycle approvals.How you'll spend your day

Provide strategic leadership and oversight for regulatory submissions (original applications, supplements, and responses) for complex generic products, specifically semi-solids, transdermals, and nasal sprays.
Drive early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals.
Lead regulatory assessments and decision-making for significant changes, including site transfers, formulation modifications, and alternate API sourcing.
Ensure submission documents are accurate, complete, and compliant with FDA regulations, promoting a Right-First-Time approach to maximize first-cycle approvals.
Represent Regulatory Affairs in global and regional forums, contributing to strategic planning and regulatory alignment.
Interpret and apply FDA regulations and guidance to both new and marketed products, ensuring compliance while fostering innovation.
Develop and implement regulatory strategies aligned with global business objectives.
Collaborate with cross-functional teams (e.g., R&D, QA, Manufacturing) to resolve regulatory challenges and streamline processes.
Champion continuous improvement initiatives and introduce innovative solutions to enhance regulatory efficiency.
Oversee regulatory documentation systems, ensuring data integrity and consistency across submissions.
Lead departmental planning, resource management, and policy development.
Mentor and develop regulatory staff, supporting leadership growth and succession planning.
Foster a culture of transparency and open communication across all levels of the organization.
Monitor and optimize key performance indicators (KPIs), including submission timelines, quality metrics, and team development goals.
Communicate organizational updates and priorities clearly and effectively to the team.
Manage departmental budgets related to regulatory submissions and administrative operations.
Serve as a delegate for senior leadership in executive forums, representing the regulatory function.
Identify and cultivate new opportunities that align with organizational goals and future capabilities.
Support internal and external audits and regulatory inspections as required.
Build and maintain strong working relationships with FDA project managers.

Your experience and qualifications

Bachelor's or Master's degree (preferred) in Pharmacy, Life Sciences, or a related field (e.g., M.Sc., Ph.D.).
Minimum 12+ years of pharmaceutical industry experience, including at least 8+ years in U.S. Regulatory Affairs with a focus on complex generic drug products including semi-solid, transdermal, and nasal spray generic drug products.
At least 6 years of proven leadership experience managing regulatory teams and complex product portfolios.
In-depth knowledge of FDA regulations (21 CFR 314.70), ICH guidelines, and eCTD submission standards.
Proficiency with regulatory systems (e.g., Veeva, TrackWise) and electronic document management platforms (e.g., Wisdom, Glorya, Livelink, Knowledgetree).
Solid understanding of pharmaceutical drug development processes.
Demonstrated success in FDA interactions, with strong negotiation and influencing skills.
Excellent verbal and written communication skills.
Experience working in matrixed, multinational environments and with third-party partners.
Lean Six Sigma certification or equivalent process improvement training is a plus.

Already Working @TEVA?If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.Teva's Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Teva Pharmaceuticals

Apply Now