34 Regulatory Documentation Jobs - Page 2

Primary Skills SAP PLM Recipe Development & Management Extensive experience in configuring and managing end-to-end recipe development processes within SAP PLM. Proficient in creating and optimizing formulas, defining ingredient compositions, and ensuring compliance with industry-specific regulations. Strong understanding of managing recipe versions, tracking modifications, and maintaining historical records for transparency and traceability. Specification and Compliance Management In-depth knowledge of handling raw material, intermediate, and finished product specifications. Ability to set up structured specification templates, define critical parameters, and ensure adherence to global regulatory and quality standards such as ISO, GMP, and HACCP. Expertise in managing allergen declarations, nutritional information, and safety data sheets within SAP PLM. Integration with Production & Quality Modules Hands-on experience in integrating SAP PLM Recipe with SAP PP (Production Planning), QM (Quality Management), and EHS (Environment, Health, and Safety). Ensures smooth data flow between product development, manufacturing, and quality assurance teams, enabling real-time collaboration and efficient production workflows. Labeling and Regulatory Compliance Strong understanding of managing labeling requirements, ingredient declarations, and regulatory documentation. Experience in configuring label templates, automating ingredient statements, and ensuring compliance with global regulatory bodies such as FDA (U.S. Food and Drug Administration), EU regulations, FSSAI (Food Safety and Standards Authority of India), and other industry-specific standards. Ensures that product labels accurately reflect composition, nutritional values, and allergen warnings. Workflow Automation and Change Management Expertise in streamlining and automating workflows for recipe approvals, change management, and version control. Proficient in setting up automated notifications, multi-level approval processes, and audit trails to enhance product development efficiency. Ensures that all changes to recipes, ingredients, and specifications are systematically tracked, approved, and implemented with minimal disruptions. Secondary Skills Experience with SAP PLM Web UI and Fiori applications for enhanced user experience. Understanding of SAP S/4HANA PLM functionalities and data migration from legacy systems. Knowledge of integrating SAP PLM Recipe with external LIMS (Laboratory Information Management Systems). Familiarity with PLM collaboration tools for cross-functional teamwork. Experience in troubleshooting PLM Recipe-related performance and data inconsistencies.

As a Regulatory Affairs Specialist at Lifesigns, you will be responsible for regulatory submissions, compliance, and documentation to ensure adherence to medical device regulations across jurisdictions. You will assist in maintaining regulatory files, managing product registrations, responding to regulatory inquiries, and supporting external audits. Your expertise in regulatory approvals, standards compliance, and medical device reporting will be essential in securing and maintaining market access for Lifesigns' solutions. Key Responsibilities Prepare, analyze, and edit technical documents for regulatory submissions in India, the USA, and Northeast Asia. Work with internal teams to ensure compliance with submission requirements and documentation standards. Maintain and update regulatory files, registrations, and listings, including ISO, CDSCO, 510(k), CE dossiers for EU, and NRTL certifications. Support renewals, device listings, site registrations, supplements, and annual reports. Prepare responses to regulatory authority queries within assigned timelines. Stay updated on regulatory procedures, industry guidelines, and compliance changes. Assess device-related incidents/complaints for medical device reporting (MDR) requirements and submit reports as needed. Handle recalls and field actions, ensuring timely reporting to regulatory bodies. Review and approve product labels and promotional materials for compliance with applicable regulations and technical standards. Provide regulatory support during external audits, helping minimize risks of non-compliance. Assist in clinical trial site ethics review board applications and prepare interim or final reports for review boards. Perform other regulatory duties as assigned. Qualifications B.E. in any discipline (preferably BME, ECE, or Mechanical Engineering). 3 5 years of experience in regulatory affairs within the medical device industry. Strong understanding of global regulatory frameworks, including FDA, CDSCO, ISO, MDR, and CE requirements. Experience in regulatory documentation, compliance management, and submission processes. What We Offer Competitive salary and performance-based incentives. Opportunities for professional growth and career advancement. Comprehensive training programs and continuous learning opportunities. A supportive and collaborative work environment. The chance to make a significant impact on healthcare technology compliance.

Department - Clinical Reporting Unit Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment. The position The key responsibilities in this position will be to perform medical writing tasks of high complexity and act as project manager. Plan, develop and oversee regulatory documents across all phases including but not limited to preparation of Protocols, Clinical Trial Reports (CTRs), non-interventional study reports (NSRs), Meeting packages and briefing book, Investigator Brochure (IB), Regulatory response documents (Q&A), Clinical summaries and Clinical overviews (NDA/MAAs). In this position, you need to lead, set direction, drive discussions, ensure decisions are taken and influence and implement project strategy. You will have to communicate the clinical data in a clear and concise manner. You will contribute to process improvements, knowledge sharing, skill building, and mentor and train other medical writers as needed. You will have to maintain good relationship with the stakeholders and colleagues. Ensure timely, clear, and proactive communication and collaboration with the stakeholders and colleagues globally. Assume role as Project Medical Writer (PMW), Clinical Submission Team Lead (CST) for assigned project. Responsible in order to meet timelines, the medical writer must be good at planning own work and be proactive when problems arise and seek help and advice from relevant people within GBS as well as within HQ. Support execution of Clinical Reporting strategy and vision in line with the leadership team. You will challenge the expert contributors on the clinical documents where the quality of their written contribution could be improved. Qualification You are expected to have the below skills and knowledge: Graduate (PhD, MSc., M Pharm, or equivalent). 10+ years of experience as medical writer or other relevant work experience. Experience in regulatory medical writing, Clinical study Report (CSR), protocol, IB, informed consent and clinical summaries and clinical overviews. Excellent understanding of clinical development and regulatory processes and requirements. Experience working within a global setting. Experience from the pharmaceutical /CRO industry. Strong understanding of external requirements related to regulatory documents. Strong analytical skills. Excellent communication and presentation skills. Committed, persistent and accountable. Able to handle numerous tasks simultaneously. Requires good communication and analytical skills. Demonstrated ability to identify better practice and create improvements in methods, techniques, approaches etc. Established record of being a proactive team-player and able to deliver on time and with high quality.

DEPARTMENT: Corporate Solutions As a member of the COSEC Team you will be expected to work in collaboration with other members of the Team, assist and support in providing administrative, compliance and regulatory services of to overseas client Companies, in accordance with applicable policies and procedures, regulatory requirements, service levels and company standards so as to satisfactorily meet client expectations. The Role: Understanding corporate and legal compliances as per jurisdiction in which client companies are located. Handling compliances and documentation under the applicable anti-money laundering regulations. Handling compliance relating to Board Meetings of overseas client companies as per applicable jurisdiction including scheduling of meeting, preparing agenda and compiling board packs and circulation of the same to directors. Handling compliances relating to annual meetings of overseas client companies. Attend Board Meetings and make notes for drafting board resolutions and minutes within applicable internal timelines and getting the same approved and signed by directors / Chairman. Updating / renewing all regulatory documents of the client companies including statutory registers, returns, registrations, licenses, certificates, insurance, etc. and filling up applications, forms and uploading / downloading of documents required for the same. Assisting the team in providing required documents for various purposes including banking and taxation requirements. Assisting in audits including internal audits and risk assessments and reviews. Maintaining and updating trackers as maintained by clients or internally and ensuring data integrity and confidentiality of internal and client information. Drafting and vetting of agreements, contracts and documents. Preparation of SOPs and training material for understanding and benefit of the team members. To provide administrative and regulatory support to Client Services Team as well as COSEC team as and when required. The Skills: Excellent drafting skills including drafting of agenda, resolutions, minutes, reports, agreements, etc. Ability to learn and grasp new compliance concepts and global compliances applicable to overseas clients. Strong work ethic. Adapting and flexible approach towards learning new systems and operational procedures. Ability to work under pressure and tight timelines, excellent time management and multi-tasking skills. Strong interpersonal, verbal and non-verbal communication skills. Team Player with excellent collaborative, analytical, problem solving and organisational skills. Result oriented, detail oriented, team player with ability to work effectively with minimum supervision, in a fast paced, complex and dynamic environment. Efficient MS Office skills (including MS Outlook, MS Word, MS Excel, MS PowerPoint) Qualifications Company Secretary;. Experience in handling compliances under Anti-Money Laundering Regulations will be an added advantage.

Responsibilities : To prepare dossiers as per CTD/ACTD guidelines for product registration, renewal & variation applications to submit in regulated / semi regulated countries. To arrange administrative documents required for dossier submission & export purpose (Manufacturing Lic, WHO-GMP, P.P/COPPs/FSCProcuring and legalization). To check & approve the artworks for regulated / semi regulated countries. To Co-ordinate and follow-up with manufacturer for documents & samples/WS required for regulatory submission. Handling queries pertaining to regulatory submissions from various regulatory authorities. Maintain record of samples, shade cards, registration certificate etc. Desired profile of the candidate : - Should have good communication skill. Good technical knowledge, review skills, and understanding of regulatory submissions. Good leadership and organizational skills, with a strong focus on execution and follow-through. Minimum Exp. : - 8 years in Regulatory Affairs Maximum Exp. : - 15 years in Regulatory Affairs Education : - B.Pharma / M.Pharma / B.Sc / M.Sc

DRA Manager Experience- 15+ years Salary Package- 13-17 LPA Must have experience in regulatory Countries dossier preparation and working Should have worked in Injectable Unit location- Baddi Himachal Pradesh

(2 -4) Years of Work Experience in regulatory. WHO Collaborative countries having knowledge of Regulatory guideline viz ICH, EMEA , PIC.

Job Details for Executive Regulatory Affairs Compilation of DMF in eCTD format and submit to regulated and semi regulated markets. Review and co-ordinate with other cross functional teams for responding the queries raised by regulatory authorities to the submitted DMF within timeline. Review of post approval changes and technical requirements as per regulatory perspective for submission of Amendment/Variation to respective countries. Handling the marketing requests and respond to customer queries Review of Specifications and analytical related documents for submission purpose. Review of technical documents like Batch records, Process validation reports, analytical method validation reports etc. Assessment of change proposals from regulatory perspective. Regulatory compliance for assigned projects of advanced markets (USA, EU, Japan, Brazil, China) Preparation & Submission of Annual reports of USDMF products for all minor changes of Commercial and Exhibit products. Maintaining the database of post approval DMF Amendment/variation submissions and their approval status with implementation details. Maintaining log for Product History as per regulatory perspective. Good understanding of cGMP

JOB SUMMARY: Knowledgeable in all disciplines of ecotoxicology, including aquatic, plants, avian, mammals, and terrestrial. Conduct ecotoxicological risk assessments and provide expert guidance to internal colleagues on ecotoxicology issues, including responses to Regulatory decisions, Data Call In reviews and recommendations, and planning defense strategies around ecotoxicology concerns. Experience with interacting with regional Regulatory Agencies especially US-EPA and European Authorities. Familiar with global data requirements, including North America, Brazil, LATAM, and Europe. Contract ecotoxicology studies at external labs. Interpret study results and implications of results. Provide expert advice on regulatory issues. Work closely with the Global Regulatory and Regional Managers to address ecotoxicology concerns in a fast paced, challenging environment. JOB RESPONSIBILITIES: Act as internal expert on the ecotoxicology profile of UPL products Prepare critical reviews, risk assessments, white papers, and position statements Develop study designs, contract and monitor studies in CROs that meet national and international regulatory requirements. Ensure study quality, costs, timelines and reporting requirements are met Work collaboratively in multidisciplinary project teams with other scientists, global and regional regulatory managers and other colleagues to ensure business goals are met Keep abreast of changing regulatory requirements and how they may impact the UPL product portfolio Proactively identify potential future challenges for our products and provide strategies to address those challenges REQUIRED EDUCATION AND EXPERIENCE: Higher degree, MSc or Ph.D. in ecotoxicology. 10-15 years of experience, with at least 1/3 of it in a global regulatory ecotoxicology role. Demonstrated knowledge of global pesticide regulatory requirements. Problem solving, strategic thinking, decisive thinking, networking, legislation interpretation, commercial awareness. Experience in conducting a variety of ecotoxicology studies, with a focus on pollinators Lead major projects and/or multiple projects involving collaboration with marketing, development and regulatory affairs Responsible for own conclusions/recommendations and determining any potential impact to business Excellent problem-solving skills and ability to think logically and systematically Self-starter. Must possess initiative and motivation to work with a minimum of guidance Good interpersonal skills