Sr Manager - Regulatory Affairs For A Pharma

Sr Manager - Regulatory Affairs for a Pharma Hyderabad Hiring for A manufactures and markets a comprehensive portfolio of Oncology products 10 - 15 YearsHyderabad Job Description Job Descripton Provide responses to regulatory agencies regarding product information or issues. Develop and maintain standard operating procedures or local working practices. 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 trials, BE studies and other protocols. 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 determinepotential 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. 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. Monitor regulatory affairs trends that are related to environmental issues. Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes Salary Not Disclosed by Recruiter Industry Pharma / Biotech / Clinical Research Functional Area Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology Role Category Drug Regulatory Affairs/Documentation Role Regulatory Affairs Manager Employment Type Permanent Job, Full Time Keyskills Regulatory ComplianceRegulatory AffairsClinical TrialsStandard Operating ProceduresDesign DevelopmentCritical CareOncology Desired Candidate Profile Qualification Bachelor Degree in a scientific discipline. Experience 10 - 15 years experience in Regulatory Affairs from a Pharma industry. Candidates worked with crtical care and Oncology stream are preferred. Experience in preparing and filing complete ANDAs, Supplements, Amendments and Annual Reports to various Regulatory authorities. Thorough understanding of the CFR, FDA/ICH guidelines and cGMPs, as they pertain to pharmaceuticals. Familiarity with eCTD and Sharepoint. Proficiency accessing documentation utilizing multiple electronic systems. Forward your resume to ideal4idealconsultants.com EducationUG -B.Sc - Any Specialization PG - MS/M.Sc(Science) - Any Specialization Company Profile Ideal Placement and Consultants (P) Ltd. A manufactures and markets a comprehensive portfolio of Oncology products and a vital portfolio of critical care products with a commitment to deliver wellness across the globe.

Salary : 360000 - 680000 Required Skills : English Job Location : Secunderabad Hyderabad Industries : Research & Academia

Job Opening Date : 27/7/2018