6 Us Fda Jobs

Alkem Laboratories Limited is an Indian multinational pharmaceutical company based in Mumbai, specializing in the manufacturing and distribution of pharmaceutical generics, formulations, and nutraceuticals across India and over 50 countries globally. Renowned for its top-tier pharmaceutical brands like Clavam, Pan, Pan-D, and Taxim-O, Alkem has consistently secured a position among India's top five pharmaceutical companies. As the IT Business Partner for SCM & Logistics at Alkem, your primary role is to serve as a strategic technology advisor, ensuring that IT solutions are aligned with the company's business objectives for the Supply Chain and Logistics functions. Your responsibilities include optimizing supply chain operations, enhancing logistics processes, and ensuring compliance with pharmaceutical industry regulations. Key responsibilities of the role involve: - Acting as the main IT liaison for Supply Chain, Procurement, and Logistics teams, translating business requirements into strategic IT roadmaps. - Developing and implementing a digital transformation strategy for supply chain operations, focusing on visibility, cost optimization, and automation. - Ensuring IT systems adhere to Indian pharmaceutical regulations, global GxP standards, and data integrity policies to support compliance and operational efficiency. You will be instrumental in: - Leading the enhancement of SAP S/4HANA SCM and IBP solutions to streamline supply chain operations. - Driving warehouse automation through technologies like IoT, RPA, RFID, and AI/ML-based demand forecasting. - Enabling real-time tracking of raw materials, inventory, and finished goods using supply chain analytics and predictive modeling. Your role also includes: - Optimizing inventory management, demand planning, and supplier collaboration through IT-driven insights and analytics. - Supporting serialization, Track & Trace, and regulatory compliance using blockchain or digital ledger technologies. - Improving order fulfillment rates and reducing logistics costs through the implementation of digital tools and automation. Moreover, you will: - Collaborate with SAP partners, IT vendors, and third-party logistics providers to ensure seamless integrations and high system availability. - Work closely with cross-functional teams including manufacturing, procurement, quality, and finance to drive supply chain enhancements. - Establish and maintain robust governance for IT projects, budgets, and vendor SLAs related to supply chain operations. The ideal candidate will possess: - A Bachelor's degree in Computer Science and a Master's degree in Supply Chain Management. - Over 10 years of experience in SCM & Logistics IT leadership roles within the pharmaceutical manufacturing sector. - Proficiency in SAP S/4HANA SCM and any Supply Chain Forecasting tool. - Hands-on experience with automation technologies such as RPA, AI/ML, IoT, and logistics analytics. - Strong knowledge of compliance standards including GMP, GxP, US FDA, EU GMP, CDSCO, and serialization. - Exceptional stakeholder management, project management, and vendor negotiation skills.,

You should have a minimum of 5 years of experience in the packing department within the pharmaceutical, healthcare, or food processing industry. Your experience should include familiarity with Lean, OEE, and similar KPIs, as well as hands-on experience with UK MHRA or US FDA procedures. Additionally, you should have experience in equipment procurement, installation, startup, validation, and trial production run of a new WHO GMP compliant packing facility. As a part of your duties and responsibilities, you will be required to manage the packaging processes, ensure and control packaging activities, monitor yield losses during the packaging process, and ensure cost-effective packing material consumption on commercial batches. You will also need to initiate plans and processes to minimize manufacturing costs, complete and review batch records and documents online, prepare and review SOPs related to packaging activities, provide on-the-job training to executives and technicians regarding packaging, coordinate with QA and QC for validation and in-process checks and approvals, and maintain and monitor cGMP standards throughout the entire process activity. The office location for this position is in Surat. To apply for this job, please click the button below and provide your full name, gender, university name, and attach your CV. In the title section, clearly state the position you are applying for. We look forward to hearing from you soon!,

This is a full-time on-site role for a Manager / Deputy Manager Regulatory Affairs located in Vadodara. As the Manager / Deputy Manager, your responsibilities will include developing and implementing regulatory strategies, ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and maintaining regulatory files. Your role will involve interacting with regulatory agencies, managing timelines, and ensuring that all products meet regulatory standards. Your key responsibilities will be to develop and direct global regulatory strategies for clinical, non-clinical, and CMC aspects. You will lead the preparation, review, and approval of submission documents for US FDA, EMA, Health Canada, Australia, and ANVISA. Providing strategic guidance on the impact of CMC changes on regulatory submissions and developing appropriate regulatory pathways will be crucial aspects of your role. Additionally, you will review and evaluate CMC documents, including specifications, batch records, stability data, and change controls. Collaboration with cross-functional teams to ensure regulatory compliance and timely submission will be essential. You will also participate in client discussions, training, and development activities as needed. Experience in handling teams and a total experience of 12 to 15 years is required for this role. Qualifications for this position include experience in regulatory strategy development and implementation, proficiency in preparing and submitting regulatory documents, a strong understanding of regulatory compliance, excellent organizational and timeline management skills, strong written and verbal communication skills, and the ability to interact effectively with regulatory agencies. Experience in the pharmaceutical industry is a plus, and a Bachelor's degree in Pharmacy, Chemistry, or a related field is required.,

Job Title: QARA ENGINEER Experience: 4.5 to 10 years Location: Bangalore Mandatory Skill: US FDA, 510K, PMA, EU MDR, QARA. Regulatory gap assessment and remediation. Job Description: The objective of this project is to identify and remediate any deficiencies in the design history files (DHF) and device master records (DMR) of the stent graft integrated with 4 branched vascular prosthesis - FROZENIX 4 Branched, ensuring adherence to relevant standards, US Food and Drug Administration ("FDA") guidelines and regulations requirements by completing all necessary tasks including document translation (Japanese to English), gap assessment, remediation and submission query support. Design verification and Validation US FDA 510k submission process US FDA Premarket approval ISO 14971 - Medical device risk management DHF Gap assessment DMR Gap assessment EU MDR 2017/745 regulations CE Technical documentation Technical standards and guidance (for medical device) ISO 60601 Electrical safety IEC 62304 - Human factors and Usability engineering ISO 10993 - Biocompatibility testing

We are looking for a meticulous Executive/Sr. Executive to spearhead regulatory submissions and review at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in ensuring our API manufacturing processes adhere to global pharmaceutical regulations. Your expertise will be essential in compiling, reviewing, and submitting comprehensive regulatory documentation to various health authorities, including the US FDA, EMA, and CDSCO. You will manage regulatory inspections, handle queries, and lead the preparation of DMF filings. The ideal candidate will possess a deep understanding of regulatory guidelines, ICH guidelines, and relevant pharmacopeias (USP, EP, BP), coupled with experience in process validation and variation submissions. Your responsibilities will extend to maintaining robust electronic document management systems (EDMS) and ensuring manufacturing records align with regulatory requirements. This position demands a proactive individual with excellent communication skills to effectively liaise with regulatory agencies and internal stakeholders, ensuring Synnat Pharma maintains its commitment to quality and compliance in the pharmaceutical industry. Job Details: Industry: Pharmaceutical (API Division) Department: Regulatory Affairs Role: Executive/Sr. Executive Location: Visakhapatnam Compensation: 5,00,000 - 10,00,000 INR per annum Experience: 5-9 years Qualification: Bachelor's degree in Pharmacy, Chemistry, or related field Responsibilities: R egulatory Submissions & Documentation: Prepare, review, and submit comprehensive regulatory dossiers and technical documentation for API products to various health authorities (US FDA, EMA, CDSCO). Manage the compilation, archiving, and tracking of all regulatory documentation using electronic document management systems (EDMS). Ensure all regulatory submissions are accurate, complete, and compliant with current regulatory guidelines and requirements. Maintain up-to-date knowledge of changes in pharmaceutical regulations and guidelines and communicate these changes to relevant stakeholders. Prepare and manage Drug Master File (DMF) filings, renewals, and updates, ensuring timely submissions and compliance. Coordinate with cross-functional teams (manufacturing, quality control, R&D) to gather necessary data and documentation. Regulatory Compliance & Inspections: Lead and manage regulatory inspections conducted by health authorities, ensuring preparedness and compliance. Develop and implement corrective and preventive actions (CAPA) in response to inspection findings and regulatory queries. Conduct internal audits to ensure compliance with pharmaceutical regulations and quality standards related to API manufacturing. Review manufacturing records and analytical data to ensure compliance with regulatory requirements and guidelines. Monitor and ensure adherence to pharmacopeias (USP, EP, BP) and ICH guidelines in API manufacturing processes. Maintain a thorough understanding of API manufacturing regulatory compliance. Regulatory Communication & Liaison: Act as the primary point of contact for communication with regulatory agencies regarding submissions, queries, and inspections. Prepare and manage responses to regulatory queries and deficiency letters, ensuring timely and accurate information. Liaise with internal stakeholders to address regulatory issues and provide guidance on compliance matters. Communicate regulatory updates and changes to relevant departments. Cultivate and maintain positive relationships with regulatory agencies. Provide support and guidance to cross-functional teams on regulatory expectations. Variation & Renewal Management Prepare and submit variation applications for changes to approved API manufacturing processes and formulations. Manage the renewal process for existing regulatory approvals, ensuring timely submissions and compliance. Assess the impact of proposed changes on regulatory filings and ensure appropriate documentation is prepared. Track the status of variation and renewal applications and communicate updates to stakeholders. Ensure all variations and renewals align with current regulatory guidelines. Maintain a comprehensive record of all variations and renewals submitted General Expectations and Past Experiences: Possess a Bachelor's degree in Pharmacy, Chemistry, or a related scientific field. Demonstrated experience (6-9 years) in regulatory affairs within the pharmaceutical industry, specifically in API manufacturing. Proven expertise in preparing and managing DMF filings and regulatory submissions for global health authorities (US FDA, EMA, CDSCO). Strong knowledge of pharmaceutical regulations, ICH guidelines, and pharmacopeias (USP, EP, BP). Experienced in regulatory inspections and responding to regulatory queries and deficiency letters. Proficient in EDMS and other relevant documentation systems. Excellent communication, interpersonal, and problem-solving skills with the ability to work cross-functionally.

Studying Legal Documents and collating info in a variety of formats. Ensuring compliance with regulations set by the Cosmetics & Perfumes Regulatory Agency as country wise Keeping up to date with changes in regulatory legislation and guidelines Required Candidate profile Well versed with US FDA, EU regulatory requirements Be well versed in the preparation of MSDS, COA, PIF and CPNP files Knowledge on Indian Drug & Cosmetic mfg Act especially on Schedule S Stds & GMP.