4 Transdermal 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.

Role & responsibilities Solid Oral - Production & Packing Officer - Executive and Plant Operator - Technical Assistant : Tablet/ Capsule - Granulation, Compression, Coating, Inspection, Capsule Filling and Wurster coater. Tablet/ Capsule - Blister Line (BQS), CVC Bottle Line Warehouse (Supervisor / Machine Operator): Officer Senior Executive and Plant Operator - Technical Assistant: RM, PM, FG, Dispensing, Dispatch , Documentation Engineering Executive/Sr. Executive: Process Equipment (Mechanical/Electrical/Instrumentation) of OSD Plant like preventive maintenance and breakdown related activities of equipment of OSD plant such as FBD, FBP, RMG, coating, compression, capsule, Packing machine etc. Technician: Process equipment's- Fitter/Electrician/ Instrumentation: Handling preventive maintenance and breakdown of equipment of OSD Plant such as FBD, FBP, RMG, coating, compression, capsule, sifter, stirrer, Wurster coater, packing machine etc. HVAC Operator - Operation and maintenance of AHU, Cooling tower, BMS, Chiller Quality Assurance (IPQA) Officer / Senior Executive: IPQA in process (Mfg. and Pkg.) Quality Control (Analyst) Officer / Sr. Executive: HPLC / GC / IR / UV / Dissolution and other QC Equipment/ QC Method Validation and Transfer.

Role & responsibilities Solid Oral - Production & Packing Officer - Executive and Plant Operator - Technical Assistant : Tablet/ Capsule - Granulation, Compression, Coating, Inspection, Capsule Filling and Wurster coater. Tablet/ Capsule - Blister Line (BQS), CVC Bottle Line Warehouse (Supervisor / Machine Operator): Officer Senior Executive and Plant Operator - Technical Assistant: RM, PM, FG, Dispensing, Dispatch , Documentation Engineering Executive/Sr. Executive: Process Equipment (Mechanical/Electrical/Instrumentation) of OSD Plant like preventive maintenance and breakdown related activities of equipment of OSD plant such as FBD, FBP, RMG, coating, compression, capsule, Packing machine etc. Technician: Process equipment's- Fitter/Electrician/ Instrumentation: Handling preventive maintenance and breakdown of equipment of OSD Plant such as FBD, FBP, RMG, coating, compression, capsule, sifter, stirrer, Wurster coater, packing machine etc. HVAC Operator - Operation and maintenance of AHU, Cooling tower, BMS, Chiller Quality Assurance (IPQA) Officer / Senior Executive: IPQA in process (Mfg. and Pkg.) Quality Control (Analyst) Officer / Sr. Executive: HPLC / GC / IR / UV / Dissolution and other QC Equipment/ QC Method Validation and Transfer.

Key Accountabilities Process/ Operational: 1. Basic knowledge for Review of Pharmaceutical Development Report. 2. Basic knowledge / hands on experience of review of manufacturing documents like batch formula, batch manufacturing records, batch packaging records, yield and reconciliation, manufacturing summaries, in-process controls data, etc. 3. Basic knowledge / hands on experience of review of analytical documents like specifications, test procedures, method equivalency reports, method validation/verification reports and method transfer reports, dissolution protocols, stability protocols, extractable & leachable study reports, etc. 4. Basic knowledge / hands on experience for preparation, review and compilation of assigned ANDAs for submission. 5. Basic knowledge / hands on experience for preparation, review and compilation of Annual Reports (ANDAs/NDAs). Strategic: 1. Basic knowledge of ICH guidelines, FDA guidelines. 2. Knowledge of CTD modules 1,2 and 3.