Roles & Responsibilities

• Provide responses to regulatory agencies regarding product information or issues.
• Develop and maintain standard operating procedures or local working practices.
• Establish regulatory priorities or budgets and allocate resources and workloads.
• Maintain current knowledge of relevant regulations, including proposed and final rules.
• Manage activities such as audits, regulatory agency inspections, or product recalls.
• Participate in the development or implementation of clinical trial protocol
• Direct the preparation and submission of regulatory agency applications, reports, or correspondence
• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products
• Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
• Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
• Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
• Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
• Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
• Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met
• Contribute to the development or implementation of business unit strategic and operating plans.
• Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.
• Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions.

Desired Candidate Profile

• Master's degree in Pharmacy or equivalent .
• Minimum industry experience of 8-10 years
• Excellent command (Written and verbal) of English language and proficient knowledge of medical terminology.
• IT Literacy (MS Windows, MS Office)
• Solid understanding of drug development process, pharmaceutical legislation and scientific matter
• Familiar with ANDA, e-CTD, CTD and ACTD regulations.
• Ability to interact professionally with customers and work effectively within a team.
• Strong strategic thinking, analytical and problem-solving skills
• Excellent organizational, prioritizing and communications skills.
• Ability to manage multiple and varied tasks with attention to details
• Effective in time management to ensure project deadlines are met.
• Ability to work independently with regular oversight.