8 Cmc Documentation Jobs

You are a proactive and detail-oriented Assistant Manager in Regulatory Affairs (EU & UK) with a Masters Degree in Pharmacy (M.Pharm or equivalent) having 4 to 6 years of experience. You will be responsible for driving CMC documentation, regulatory submissions, and lifecycle management for the EU & UK markets, ensuring compliance with regional and international guidelines. Your key responsibilities will include conducting comprehensive CMC reviews of technical documentation for regulatory filings across the EU and UK markets, performing Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards, developing and implementing regulatory strategies, processes, and timelines for the preparation and submission of Marketing Authorization (MA) applications, preparing and compiling new CTD dossiers, variations, and renewals ensuring full compliance with applicable EMA/MHRA regulatory requirements and internal quality standards, critically reviewing documentation to ensure internal consistency, compliance with regulatory expectations, and support regulatory excellence, collaborating with cross-functional teams including R&D, QA, QC, Manufacturing, and external stakeholders for timely and accurate data collation and submissions, ensuring effective and efficient communication across teams to facilitate streamlined project execution and meet submission timelines, and maintaining high-level knowledge of current country-specific regulations, keeping track of regulatory updates through respective health authority websites (e.g., EMA, MHRA). You must possess strong technical skills in data analysis and interpretation of regulatory documentation, excellent interpersonal and problem-solving skills with a proactive and solution-oriented approach, effective negotiation and communication skills for liaising with internal teams and external agencies, proficiency in drafting and reviewing documents in line with global, regional, and national regulatory standards, expertise in document management systems and tools like Excel, Outlook, PowerPoint, and Word, strong presentation and reporting skills with the ability to explain complex regulatory concepts clearly, demonstrated ability to analyze data systematically, apply regulatory logic, and compile well-organized submissions, collaborative, results-driven, and self-motivated with the flexibility to adapt to shifting priorities, and capable of delivering high-quality outputs under pressure and within aggressive timelines. You should also have the flexibility to work in cross-time-zone schedules, as needed to support global project coordination or agency interactions. Joining this high-performing regulatory team will allow you to play a critical role in bringing impactful pharmaceutical products to patients globally in a collaborative, fast-paced environment where your expertise shapes international market access strategies.,

The role involves compiling, preparing, reviewing, and submitting ANDA submissions and Amendments to FDA with the aim of avoiding major deficiencies and obtaining approval within the shortest possible timeframes. It is essential to stay informed about all regulatory activities on assigned projects, set and meet project deadlines and performance standards. Expertise or prior experience in Sterile dosage form ANDAs is required, particularly in areas such as Injectables, Ophthalmic, Otic, and IV Bags with knowledge of Aseptic sterilization, Terminal sterilization, or both techniques. Timely submission of assigned projects, review, and preparation of documents meeting US FDA requirements without query or RTR are key responsibilities. It is important to evaluate change controls, formulate filing strategies, and proactively address major issues. Collaboration with various departments during product initiation, R&D phase, ANDA/Bio Execution, and post-stability initiation is necessary for timely document availability and submissions. Additionally, preparing controlled correspondence and meeting packages for FDA on specific issues, assessing deficiency letters, and developing regulatory strategies are crucial tasks. The position requires maintaining accuracy and attention to detail, excellent written and verbal communication skills, and prior experience with ANDAs, INDs, NDAs, and FDA correspondences. Time management, organization, and multitasking abilities in a fast-paced environment are essential. Effective communication and collaboration within a team, working independently, and adhering to regulatory guidelines are important aspects of the role. Strong computer skills, familiarity with ICH, FDA, and 21 CFR regulations, and the ability to handle administrative functions to support projects are also necessary. The required skills include expertise in regulatory submission and dossier filing, regulatory guidelines knowledge, cross-functional communication, change management, problem-solving, product lifecycle management, CMC documentation, health authority query response, and regulatory strategy development. The qualifications needed for this role include an M. Pharm degree. Amneal is an equal opportunity employer that values diversity and inclusion in the workplace. The Human Resources team plays a vital role in the organization, providing support in people management, compliance, talent acquisition, learning and development, reward systems, and performance management. They also offer expert advice on workforce management, employee relations, and stay updated on developments impacting employment matters.,

As a Technical and Scientific Leader in upstream processes for early-stage development, you will play a crucial role in ensuring the seamless handover of Suns Branded Portfolio products from development to commercialization. Your responsibilities will include providing quality input into CMC strategy, representing quality oversight in various stages of process development, and contributing to the planning of Clinical trial materials. You will also collaborate with cross-functional teams to facilitate a smooth transition to Commercial QA and manufacturing. Your scientific leadership will be instrumental in supporting process and product investigations, troubleshooting issues, and identifying opportunities for improvement. You will be expected to leverage your technical expertise to oversee experimental planning, analyze development results, and review manufacturing data. Additionally, you will be responsible for authoring and reviewing CMC documentation for regulatory filings, as well as providing support during health agency inspections. In order to excel in this role, you must possess an MS or PhD in chemical/biochemical engineering, biochemistry, or a related field, along with a minimum of 10 years of relevant experience. A proven track record of technical manufacturing experience, the ability to drive technical quality rigor, and strategic analysis skills are essential. Your capacity to manage multiple projects in a fast-paced environment, utilize risk-based decision-making approaches, and work collaboratively in a matrix environment will be critical to your success. Furthermore, your strong interpersonal skills, effective communication abilities, and demonstrated project management capabilities will be valuable assets in this role. Experience with audits in global regions and the flexibility to travel to the US and/or EU countries will be advantageous. If you are looking to join a dynamic Development Quality team and contribute to the advancement of Suns Branded Portfolio products, this opportunity may be the perfect fit for you.,

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. You will also handle Return Goods and ensure the smooth functioning of the quality system by performing risk assessments as required. Conducting regular internal audits and reviewing/approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be part of your duties. Additionally, you will review annual product quality review reports, provide training on cGMP topics to employees, and support customer audits/visits as well as regulatory audits. You will assist in providing necessary documents for amendments, annual updates, regulatory filings, and CMC supporting documentation. Other tasks may include filling out questionnaires, declarations, quality agreements, and executing any additional responsibilities assigned by the Head of Department.,

You should have a minimum of 5-11 years of experience in authoring high-quality CMC documentation for US FDA submissions, including Original ANDA/Deficiency responses/Post approval supplements/Annual reports. Your responsibilities will include identifying required documentation for US regulatory submissions, ensuring technical congruency and regulatory compliance, reviewing and identifying content issues with source documents, and keeping knowledge up to date with regulatory guidelines. You must have a B. Pharm/M. Pharm qualification and possess hands-on experience with eCTD software, as well as a strong understanding of CTD/eCTD requirements for submission of dossiers. Additionally, you should be proactive in identifying authoring issues, coordinating with stakeholders for technical support, and contributing to regulatory strategy and critical issue identification. Desired skills for this role include good technical knowledge, review skills, ability to try new approaches when faced with challenges, and a positive analytical and learning attitude. You will also be responsible for attending to e-publishing requirements throughout the project lifecycle and ensuring timely delivery of approved technical source documents in accordance with project timelines.,

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. In addition, you will handle Return Goods and ensure the proper functioning of the quality system by performing risk assessments as needed. Conducting regular internal audits will also be part of your duties. Reviewing and approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be crucial to ensure compliance. You will also review annual product quality review reports and provide training on cGMP topics to employees at the site. Additionally, you will support customer audits/visits and regulatory audits, as well as provide necessary documentation for amendments, annual updates, regulatory filings, and CMC supporting documentation. Your role will also involve filling out questionnaires, declarations, and quality agreements. Finally, you will execute any additional responsibilities assigned by the Head of Department.,

Role & responsibilities Regulatory Affairs Associate Description: The Regulatory Affairs Associate I assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and client standards. The Regulatory Affairs Associate I is an individual contributor who applies regulatory domain knowledge and may work under supervision. Accountabilities/Responsibilities: Document management including uploading and tracking regulatory files and systems according to established CLIENTprocedures and regulatory requirements Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches Be the interface with health authority (HA) and their systems for designated regulatory tasks e.g., management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA portals Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, certificates of pharmaceutical products, legal documentation, e.g., letters of authorisation, power of attorney, translations of regulatory documentation Provide support across the group for assigned non-drug project roles & responsibilities e.g., function as a designated point of contact or superuser Provide guidance and knowledge sharing within the RAM skill group If required, support in activities such as scheduling of regulatory submissions, PBRERs, etc. Minimum Requirements Education and Experience Relevant qualification and/or experience in science Minimum 5 years of experience from biopharmaceutical industry, or other relevant experience Proficient verbal and written English Project management skills Experience in document management and tracking databases Preferred Experience Some regulatory/medical/technical experience Knowledge of CLIENTbusiness and processes Some knowledge of CLIENT”submissions, compilation, publishing and approval processes, standards, systems and tools Experience of collaborating with people from locations outside of India, especially Europe and/or USA Skills and Capabilities Good written and verbal communication skills in English Cultural awareness Proficiency with common document management tools Ability to work independently and as part of a team Focus on continuous improvement and knowledge sharing Internal and External Contacts/Customers Lead RPM and members of the Global Regulatory Execution Team (GRET) and Global Regulatory Strategy Team (GRST) Other R&D skill groups, e.g., GRO, Operations Regulatory, Patient Safety, Reg TA (GRL & Regional Leads) Marketing companies Health authorities External collaboration partners “client” Legal “CLIENT”vendors for translation, document authentication, etc. Interested candidate Kindly drop your updated resume to below mail id Nithya_kumar@persolkelly.com Regards, Nithya CONFIDENTIAL NOTE: By submitting your resume or personal data, you acknowledge reading and agreeing to our Privacy Policy. You hereby provide voluntary consent to the collection, use, processing, and disclosure of your data by us and our affiliates, in line with the Privacy Policy. and applicable laws. If you wish to withdraw your consent or have any concerns, you may submit a request to our designated consent manager, as outlined in our Privacy Policy. We prioritize your privacy. SECURITY NOTE: We at PERSOLKELLY India or our representatives, do not ask job seekers for fees, personal banking information, or payments through unofficial channels. Official communications will only come from @persolkelly.com. Report any suspicious activity to Contactus_in@persolkelly.com. Click here to find out how you can safeguard yourself from job scams

This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance s 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 we re 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 (eg, 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 Bachelor s 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.