7 Post Approval Jobs

Regulatory Affairs Associate Experience: 3-6 years Education: Science Graduate Location: Hyderabad Skills: Regulatory Affairs, EU market, Formulation, RA, European market, Post and Pre approval

Primary Responsibilities: Responsible for finalizing the CMC regulatory strategies for assigned products and provide support to execute tasks independently in accordance with global regulations and guidance procedures. Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. Execute regulatory strategies by leading the development, Review and approval of CMC submission components and documentation to support post-approval supplements, and responses to health authority questions per established business processes and systems. Lead the Change control evaluation, preparation, and submission of CMC dossiers for life-cycle changes to commercial products in support of project execution. Lead & plan the bundling/grouping strategy of variations and geo-expansion strategy of active Marketed products. Aid in the development and Lead execution of global product and project regulatory strategy(s) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks. Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal. Collaborate with internal and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance. Manage execution of CMC documentation including complex post-approval variations, registration renewals and responses to health authority questions per established business processes and systems. Demonstrate a robust understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity. Assess and communicate potential regulatory risks and propose mitigation strategies. Deliver all regulatory milestones for assigned products across the product lifecycle Identify, communicate, and escalate potential regulatory issues to management, as needed. Demonstrate ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders. Demonstrate flexibility in responding to changing priorities or dealing with unexpected events. Demonstrate effective leadership, communication, interpersonal and negotiating skills in the most complex and fast-paced team environments. Experience required: Bachelor's / Master's / Ph. D. degree in science, engineering, or related field. 5+ years of experience is preferred. Strong experience in CMC registration and Pre & post approval submission activities. Proven experience in critically reviewing the supporting documents and data to ensure the adequacy for submission. Superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills. Sound understanding of related fields (e.g., manufacturing, analytical, quality assurance and other related fields) and the ability to be creative and imaginative in the approach to new and diverse problem solving. Relevant CMC pre/post approval experience, which may include research, manufacturing, testing, or licensure of products. Role & responsibilities Preferred candidate profile

Reporting to Sr. Director - Regulatory Affairs Experience required: 5-8 Years Education: B. Pharm / M. Pharm Department: Regulatory Affairs Key Responsibilities: Prepare the status of all documents related to submission. Compile and review Regulatory submission documents required in line with the relevant guidelines. Coordinate with all stakeholders of the manufacturing plant for the collection of documents. Evaluation of change control: evaluate all post-approval changes. Review of specifications (API, Intermediate, FP, and Shelf life) executed BMRs, BPRs, COA, Method transfer report, Method verification, Analytical chromatograms intended for regulated or non-regulated market submission. General Review of plant Site Master File, layouts, and valid GMP Compliance Certificate for its adequacy to support regulatory submission. Effectively implement post-approval commitment. Preferred candidate profile Review of CMC (Chemistry, Manufacturing, and Controls) Documents Self-motivated, detail-oriented, and highly organized professional Proven ability to collaborate and communicate effectively with diverse teams Proficient in Microsoft Word, Excel, and PowerPoint Fluent in English, with strong skills in speaking, comprehension, reading, and writing. Strong technical expertise in reviewing manufacturing site documentation.

Opening for - Manager, Regulatory Affairs - CMC@ Mumbai , Pune and Hyderabad location. Experience : 5 to 10 Yrs relevant experience in RA CMC This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies. He would even be responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. Your role at our organization is integral to helping the world meet new breakthroughs that affect generations to come, and were counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks. Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements/variations, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Liaise with global CMC, Our Manufacturing Division and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance. Assess and communicate potential regulatory risks and propose mitigation strategies. Deliver all regulatory milestones for assigned products across the product lifecycle Identify and communicate potential regulatory issues to GRACS CMC management, as needed Technical Skills: Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data. Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills. Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance). Proficient computer skills and previously demonstrated ability to operate in electronic document based GMP systems Leadership Skills: Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Capability to handle multiple priorities and balance work to achieve business goals. Demonstrated effective leadership, communication, and interpersonal skills Qualifications & Skills Bachelors in Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry Minimum 5 7 yrs of Industry Pharmaceutical industry experience out of 4 years’ experience in managing CMC Regulatory submissions for small molecules/vaccines/biologics The candidate may be required to travel to other CMO sites on a need basis. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Role & responsibilities With moderate to minimal guidance, prepare, review, and compile new submissions, deficiency responses (IRs, DRLs, CRLs), and amendments using the "Right-First Time" approach. Work with their manager to support early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals. Support regulatory assessments and decision-making for significant changes, including site transfers and alternate API sourcing. On occasion, serve as regulatory contact point for cross-functional teams like R&D, QA, Manufacturing & Packaging sites, DMF holders, etc. Monitor and manage regulatory timelines and proactively address data or document gaps. Evaluate and classify change controls for regulatory impact and determine appropriate submission pathways. Compile and submit post-approval changes (PAS, CBE-30, CBE-0, AR) ensuring compliance with FDA, ICH, and internal requirements. Track regulatory guidance updates, stay current with evolving regulatory requirements. Monitor relevant FDA databases (e.g., Drugs@FDA, Orange Book) and ensure internal stakeholders are informed of critical changes. Participate in audits, inspections, and process improvement initiatives. Preferred candidate profile Masters degree in RA/QA discipline, preferably in Pharma. Minimum 4+ years pharmaceutical industry experience with sterile products ; Regulatory, Analytical, QA, laboratory or production experience preferred. Demonstrates an understanding of ICH and FDA guidelines Demonstrates excellent verbal and written communication skills. Demonstrates excellent organization skills and the ability to multi-task; detail oriented. Possesses strong critical and logical thinking.

RESPONSIBILITIES Author high- quality CMC documentation for US FDA submissions for Post approval supplements/Annual reports in accordance with latest guidance assuring technical congruency and regulatory compliance. Tracking labeling updates and handle corresponding CBE-0 filing. Provide support in PADER submissions. Review and Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues proactively Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends Co-ordination with stakeholders on a regular basis to extend all technical support required from regulatory perspective DESIRED SKILLS Hands on experience on using eCTD software and attending e-publishing requirements throughout project lifecycle. Good technical knowledge, review skills and understanding of regulatory submissions. Strong knowledge of CTD /eCTD requirements for submission of dossiers. Ability to try new approaches when faced with challenges. Should have good analytical and learning attitude.

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top management level professionals according to clients specific needs. We are BEST-FIT Recruitment Riders do exactly what our name tells. To know more about us please visit our website: www.bestfitrecruitment.co.in We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client. Please see the following position summary: Client Name: Foreign-based MNC Company Position : Sr. Manager / Assistant General Manger Department : Regulatory Affairs Market : USA Products: Solid Oral Formulations Location : Ahmedabad Job Profile: Role Objective : To lead and oversee the entire regulatory lifecycle of pharmaceutical products for the USA market, from development and pre-approval Submissions through post-approval compliance and lifecycle management, ensuring adherence to USFDA regulations and successful commercialization. To lead and manage the regulatory strategy, submission planning, and lifecycle management of pharmaceutical products for the United States market, ensuring end-to-end compliance with FDA regulations, ANDA processes, and post-approval obligations. The role includes managing cross-functional collaboration, regulatory risk mitigation, and ensuring timely product launches and updates. The candidate will ensure timely submission and compliance with all applicable FDA regulations and guidance. Pre-Approval Regulatory Activities: Develop & execute regulatory strategies for ANDA submissions & compliance. Prepare & review Regulatory Dossiers (ANDA) for initial submission to the US-FDA. Provide regulatory guidance during product development, including formulation, analytical, and clinical stages. Liaise with the USFDA for pre-submission meetings, deficiency responses, and clarifications. Manage and respond to FDA queries, deficiencies, and Information Track application progress and communicate status updates to management. Ensure data integrity, accuracy, and alignment with FDA requirements and guidance documents. Coordinate with Formulation, Analytical, Clinical, Quality, and Supply Chain teams for necessary data compilation and Module 1-5 content. Post-Approval Regulatory Management: Prepare, review, and submit Annual Reports and Post-Approval supplements to the USFDA. Track and manage post-approval commitments and risk mitigation plans as per FDA requirements. Ensure compliance with post-approval commitments and deficiency responses to the USFDA. Oversee change control reviews for manufacturing, packaging, analytical methods, and labelling updates. Monitor changes in FDA regulations and proactively update internal stakeholders and regulatory strategy. Monitor and update labelling and artwork in line with FDA guidance, safety updates, and monograph changes. Compliance & Change Control: Review and approve change controls related to manufacturing, packaging, analytical methods, and labelling from a US regulatory perspective. Ensure post-approval commitments and deficiency responses to the USFDA are submitted within stipulated timelines. Monitor and maintain product labelling in compliance with updated regulations and safety requirements. Documentation & Records: Maintain updated regulatory files, approval letters, submission archives, and correspondence with USFDA. Review and approve artwork, carton, and label proofs for compliance with USFDA labelling regulations. Ensure regulatory databases are updated with submission and approval statuses. Cross-Functional Coordination: Work closely with FRD, ARD, Clinical, Manufacturing, QA, R&D, supply chain, and packaging teams to ensure regulatory compliance during the product lifecycle. Provide regulatory training and mentoring to team members. Desired Profile: B.Pharm / M. Pharm with 10 to 15 years in Regulatory Affairs, with significant experience in both pre-approval and post-approval activities for the USA market. Exposure to working in US Markets is Mandatory. Experience in leading teams and interacting with the US-FDA. In-depth knowledge of USFDA regulatory requirements for pharma products across pre-and post-approval stages. Regulatory exposure in Europe / Canada / Australia would be added advantage. Experience in preparing Annual Reports, CBE, PAS, labelling supplements submissions. Successful track record of leading regulatory submissions and securing approvals from the USFDA. Excellent understanding of CMC documentation and pharmaceutical manufacturing processes. Skilled in regulatory writing, dossier compilation, and electronic submissions. Proven track record of successful post-approval submissions to USFDA and lifecycle management of formulations. Candidate should have exposure in Regulatory Submission & Filling on Educe Software. Proven track record of interactions with regulatory agencies. Strong project management skills with the ability to handle multiple submissions in parallel. Excellent interpersonal and communication skills for agency interactions and cross-functional coordination. Ability to compile, manage and interpret data. Strong written and verbal communication skills. Ability to independently manage projects and regulatory strategy. High attention to detail and strong organizational skills. Excellent leadership, communication, and project management abilities. High attention to detail, risk assessment capability, & solution-oriented mind-set Strong communication, negotiation, and analytical skills Recruiter Details: BEST - FIT Recruitment Riders G-7, Amrit Complex, Opp: Mahavir Jain Vidhyalaya & Jain Derasar, R.V. Desai Road, Near Goyagate Circle, Vadodara-390001, Gujarat, India Mobile: 09722052906, 09722042906 E-Mail: career@bfrr.in Website: www.bestfitrecruitment.co.in