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Job Description

Designation: Junior Manager / Assistant Manager Job Location: Bangalore Department: Quality Assurance - Regulatory AffairsAbout Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.Job Purpose: As a regulatory affairs officer, he/she will be the crucial link between his/her company, its product, clients and regulatory authorities. He/she will combine his/her knowledge of scientific and regulatory guidelines to ensure products, which are developed, manufactured or distributed, meet the required regulations.
• Products will typically involve novel molecules in various stage of development and marketing. He/she will be involved throughout the development cycle. His/her contribution will help bring the much needed therapeutics to the unmet need of the patients, thereby positively impacting the mankind.
• He/She will predominantly cater to Developed countries and to certain Emerging countries, based on the market requirement. Responsible for planning, consulting and compiling the CMC portion of the company s product / clients filing into specific international markets.
• Actively participate from initiation of the projects and provide Regulatory strategy inputs to the team and the clients. Will review dossiers, regulatory documents, response to deficiencies, on timely basis as per the business needs and regulatory norms. He/she will support to ensure timely submission and registration as per launch schedule.
• He/she will have a critical role in assessing and providing consulting for the regulatory requirements for various business aspects, especially for USFDA, EU countries, and in support of the Pre-Approval Inspections as required.
• He/she will provide consulting in regulatory compliance throughout the product development cycle as required, for both Indian and international regulations.
• Engaging with the clients on periodical basis to provide the project update, and will be responsible for Regulatory project management for the products assigned.
• He/she will require to travel to other sites within Karnataka. May travel about 30% of the time.
• Identify the regulatory requirements for International Regulatory Dossiers, Prepare checklists, author sections of dossiers and device master files, follow up with stakeholders
• Actively participate in CMC IND, NDA, MAA, ANDA content development as per project schedule. Ensure appropriate standards and content requirements are met for regulatory submissions. Compile, author and Publish eCTD Dossiers.
• Attend client telecons and support their requirements. Provide time to time update to Syngene stakeholders on the assigned regulatory activities and participate in teleconferences/ discussions with stakeholders as required.
• Archive, maintain the International regulatory documentations, including dossiers, and to ensure retrieve-ability of these documents.
• Provide consulting to stakeholders and stakeholders on regulatory requirements and strategy.
• Support all regulatory activities associated with product development, new registrations and lifecycle management as per requests from clients.
• Review plant and R&D documentation such as development reports, BMR, BPR, Specifications, method validation, process validation etc. Support Providing responses to regulatory agencies regarding product information or issues.
• Maintain all regulatory filings, Product Marketing authorization renewals to ensure continuous validity. Maintain, and update product dossiers as required to meet changes in internal systems, changes in regulatory guidelines. Should maintain all hard and soft copies and database in appropriate template/ format as deemed necessary for all submissions.
• Ensure maintenance of licenses and complete license renewals as required.
• Maintain Quality Agreement Tracker, prepare Quality Agreement Checklists and review New Quality Agreements.
• Train staff in regulatory policies or procedures. Develop and maintain standard operating procedures or local working practices.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
• Attend training on environment, health, and safety (EHS) measures imparted company.
Educational Qualification: B.Pharm / M. Pharm / Life sciences degree with minimum 5 + years of working experience with Pharmaceutical / Life science. Technical/functional Skills: High-level English Proficiency in read, write and communication Hands on Experience in eCTD. Thorough understanding of CMC (API & Drug Product) and skill in regulatory interpretations and application Must have hands-on experience with Pre-IND, End-of-Phase 1/2 and Pre-NDA submissions with FDA or similar regulatory. Experience: 6 to 9 yearsBehavioral Skills: Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team. Good speaking-listening-writing skills, attention to details, proactive self-starter. Ability to work successfully in a dynamic, ambiguous environment. Ability to meet tight deadlines and prioritize workloads. Ability to develop new ideas and creative solutions. Should able to work in team and flexible for working in shifts. Should be a focused employee.Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. ,

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