2 Generic Products Jobs

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.

You will be responsible for developing, validating, and applying pharmacokinetic and pharmacodynamic models (PopPK and PBPK modelling) to support drug development programs. This includes conducting and presenting pharmacokinetic modelling and simulation (M&S) analysis to management and technical teams for project advancement. You will also predict human pharmacokinetics based on in-silico, in-vitro, and in-vivo data, including dose scaling and profile prediction. Additionally, you will conduct IVIVE and IVIVC and work closely with cross-functional teams, including preclinical, clinical, and regulatory teams, to guide decision-making and project direction. Utilizing software tools such as WinNonlin, R, SAS, Matlab, Monolix, GastroPlus, Simcyp, PK-Sim, and other similar platforms for M&S will be an essential part of your role. Furthermore, you will be expected to develop and optimize models for bioequivalence studies, sample size determination, and regulatory submissions. Supporting regulatory filings for New Chemical Entities (NCE), 505(b)(2), and generic products will also be within your responsibilities. Your focus will be on engaging in all aspects of drug development with an emphasis on predicting human pharmacokinetic and pharmacodynamic behavior under different dosing regimens. Using advanced statistical approaches for bioequivalence analysis and large-scale data handling, you will collaborate in the development and refinement of methodologies and approaches in PK modelling. It is crucial to ensure clear communication of findings through presentations and written reports using Microsoft Excel, Word, and PowerPoint. Qualifications: - M. Pharm / Ph. D Amneal is an equal opportunity employer and does not discriminate based on caste, religion, gender, disability, or any other legally protected status. The organization values diversity and inclusion in the workplace. The Human Resources team at Amneal partners with all aspects of the organization, driving success through effective and innovative management of people for both current and future business needs. Their key roles include: - Executive Role: Specialists in all aspects of people management providing high-level input at a strategic level into all key business decisions. - Audit Role: Ensuring all areas of the organization are compliant with legal requirements and best practice employment policies and procedures. - Facilitator Role: Close partnership to support, advise, and extend the ability of all areas of the organization to meet their objectives through highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing. - Consultancy Role: Providing expert advice to the organization and its managers on any aspect of workforce management, employee relations, and performance. - Service Role: Ensuring the organization is fully aware of and equipped to deal with developments impacting employment matters, such as changes in legislation and characteristics of the labor market.,