2 Post Approvals Jobs

Role & responsibilities Management of the submission and approval process for Teva products in APAC Region (Australia, New Zealand, Singapore, Malaysia etc) to support business opportunities for the company. Management of regulatory compliance including product maintenance, data sheets, labelling, regulatory compliance files and regulatory databases. Support new product launch activities including coordinating regulatory requirements, artwork approval and providing technical input into any product related materials required for market introduction. Regulatory Submissions Manage all submissions and maintenance activities related to Branded/Specialty and Generic products in APAC region. Ensure full compliance of marketed products according to local regulations by proactively managing and monitoring change control with sites/suppliers and global RA WP. Manage local regulatory planning process for post-approval changes, including variations, site transfers and compliance related activities to support supply continuity. Manage activities within Regulatory Systems and keep up to data as per compliance requirements (GRIDS, GI Insights, Teva Art, Veeva etc) Regulatory Intelligence/Expertise/Guidance/Education Provide regulatory guidance to ensure that Teva can meet the responsibilities of an importer, distributor and sponsor, to ensure supply of safe and effective medicines, including supply of unapproved medicines, as required by Health Authorities Provide regulatory intelligence and maintain thorough and up-to-date understanding of the regulatory environment in APAC region by providing impact analysis feedback to commercial teams.. Capture monthly activities via reports and capture RA activities on an ongoing basis in the regulatory tracking system. Ensure regulatory records and files are maintained electronically for ready record retrieval and life cycle management, in accordance with global and local requirements. Monitor, collect and interpret regulatory guidelines and trends that will impact marketed and planned products, share this information with appropriate personnel and assist in the development of strategies and plans of action to address them. Work closely with market RA in APAC region to complete all assigned activities Preferred candidate profile B. Pharm / M. Pharm (preferred) with 10+ years of experience Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of human medicinal products and medical devices. Experience in Generics, Biosimilars or Innovative Medicines in Regulatory Affairs (APAC preferred) and knowledge of regulatory and healthcare system in APAC (Australia, New Zealand, Singapore, Malaysia etc)

Role & responsibilities 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 Preferred candidate profile Bachelors 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 . 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.