3210 Regulatory Affairs Jobs - Page 38

This Position reports to: Global Category Manager Your role and responsibilities In this role, you will have the responsibility for analyzing, managing, and verifying the global and integrated end to end business processes for Material Compliance , conflict minerals and sustainability across the value chain together with the Product Managers(s), P&L Function, HSE function, IS organizations and external partners/ suppliers. The work model for the role is: #LI-Onsite This role is contributing to the Process Automation business for BA Function Operation Centers and Quality division based in Bangalore, India. You will be mainly accountable for : Ensure business compliance with statutory material...

As a Regulatory Affairs Manager, you will play a crucial role in monitoring the company's production activities to ensure compliance with all applicable regulations and standard operating procedures. Your responsibilities will include devising regulation compliance strategies, creating training and orientation programs for staff, conducting internal inspections and information drives, and staying updated with the latest rules and regulations. Key Responsibilities: - Possess in-depth technical knowledge of Chemistry, Manufacturing, and Controls (CMC) aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents ac...

Role Overview: As a Manager in AERB-QC & Regulatory at Edusoft Healthcare Pvt. Ltd., your primary responsibility will be to oversee the quality control and regulatory compliance processes, including type approvals, AERB process validations, training the team, and leading the team related to AERB requirements on a day-to-day basis. This is a full-time on-site role based in New Delhi. Key Responsibilities: - Ensure compliance with AERB regulations and quality control standards - Manage new product type approvals and renewals - Implement regulatory compliance and quality control processes - Provide AERB process training to the team - Demonstrate strong analytical and problem-solving skills - Ut...

In this role, you will be responsible for the daily intake of cases from the Case Intake System into various quality and pharmacovigilance systems. You will triage inbox cases, determine their validity and seriousness, and ensure reconciliation with vendors to avoid missing any cases. Collaboration with cross-functional teams is crucial to gather necessary information for report completion and follow-up. Additionally, participating in training sessions will enhance your understanding of safety regulation procedures and pharmacovigilance practices to support team objectives. You will also partner with stakeholders in developing and reviewing SOPs related to ICSR business processes, as well as...

Role Overview: You will be responsible for working in the Product Stewardship and Regulatory Affairs domain, collaborating with cross-functional partners globally on Product Stewardship initiatives. Key Responsibilities: - Issue Product compliance certificates / declarations in response to enquiries from global customers, ensuring fast and efficient query resolutions. - Ensure compliance of Archroma products with industry-specific and Global regulatory requirements. - Assess Archroma products for various uses/applications and certifications such as Ecolabels like Bluesign, GOTS, Oeko-Tex, Cradle to Cradle, and Food contact, medical, etc. - Evaluate Archroma products in accordance with Harmon...

Role Overview: You will be responsible for delivering and driving high-quality submissions by yourself and the team in compliance with technical requirements from regulatory authorities. Your main focus will be on fixing any errors, guiding the team, and troubleshooting submissions to ensure a quality output. Additionally, you will drive a first-time-right approach by educating the team and collaborating with other operations teams and stakeholders to work towards common goals. Key Responsibilities: - Fix errors, guide the team, and troubleshoot submissions to ensure quality output - Educate the team on relevant activities to drive a first-time-right approach - Collaborate with other operati...

Roles and Responsibility Coordinate and manage regulatory submissions, ensuring compliance with relevant laws and regulations. Develop and implement effective submission strategies to achieve business objectives. Collaborate with cross-functional teams to ensure timely and accurate submissions. Conduct thorough reviews of submissions to identify areas for improvement. Maintain accurate records of submissions and follow up on pending submissions. Stay updated with changes in regulatory requirements and guidelines. Job Requirements Strong knowledge of regulatory submissions and compliance. Excellent communication and project management skills. Ability to work in a fast-paced environment and me...

Roles and Responsibility Publish regulatory submissions on time, ensuring accuracy and compliance with relevant regulations. Collaborate with cross-functional teams to prepare and review regulatory documents. Develop and maintain relationships with regulatory authorities and stakeholders. Stay updated with changes in regulatory requirements and implement necessary updates. Ensure all regulatory submissions meet required standards and quality criteria. Coordinate with internal teams to gather information and support for regulatory submissions. Job Requirements Strong knowledge of regulatory requirements and guidelines. Excellent communication and interpersonal skills. Ability to work independ...

We are looking for a skilled SDN Controller with 17+ years of experience to join our team in Bangalore. The ideal candidate will have expertise in OSS, SDN domain controller, TMF eTOM Framework, and Telecom Standards. Roles and Responsibility Manage service assurance, fulfillment, and inventory for seamless operations. Implement SDN domain controllers to optimize network performance. Develop and maintain TMF eTOM frameworks to ensure compliance with telecom standards. Collaborate with stakeholders to achieve business objectives. Analyze data to identify areas for improvement and implement changes. Ensure effective communication with internal teams and external partners. Job Requirements Stro...

We are looking for a skilled SAP FI - Asset Accounting professional with 5 to 10 years of experience. The ideal candidate will have expertise in SAP FI - Asset Accounting and be able to work effectively in a fast-paced environment. This position is available in Bangalore, Hyderabad, Pune, Chennai, Bhubaneswar, Kolkata, and Gurgaon/Noida. Roles and Responsibility Manage and maintain accurate financial records and accounts. Prepare and review financial reports, including balance sheets and income statements. Develop and implement effective accounting procedures and policies. Collaborate with cross-functional teams to achieve business objectives. Analyze financial data and provide insights to s...

1-Formulation Development 2-Pre-formulation Studies 3-Process Development & Optimization 4-Documentation 5-Technology Transfer 6-Analytical Support 7-Regulatory Compliance 8-Cross-Functional Collaboration

Dear All, We are looking for a Regulatory Affairs Assistant Manager/Deputy Manager with 7-10 years of experience in pharmaceutical formulations, specifically for the Europe market . Key Responsibilities: Prepare, compile, and submit high-quality regulatory dossiers in compliance with EU and UK market requirements. Collaborate with cross-functional teams (CFTs) to ensure alignment with regulatory standards and timely compliance Maintain accurate and up-to-date regulatory documentation and manage regulatory databases effectively. Demonstrate strong communication skills to engage with internal teams and external regulatory authorities. Possess in-depth knowledge of EU regulatory guidance, proce...

About The Role Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP EWM Good to have skills : NA Minimum 5 year of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in problem-solving act...

We are looking for a skilled Program Leader to join our team in the BPO/Call Centre industry. The ideal candidate will have 4 to 8 years of experience and be based in R1 RCM Global Private Limited. Roles and Responsibility Lead compliance programs to ensure adherence to regulatory requirements. Develop and implement effective compliance strategies to mitigate risks. Collaborate with cross-functional teams to identify and resolve compliance issues. Conduct audits and reviews to ensure compliance with industry standards. Provide training and guidance on compliance policies and procedures. Monitor and report on compliance metrics to senior management. Job Requirements Strong knowledge of compli...

Recorders and Medicare Systems Pvt Ltd is looking for RA Executive to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available ...

Regulatory Operations Manage artwork workflows in designated systems, including initiation, validation, and closure tracking. Coordinate sample ordering and documentation for import authorization. Update regulatory databases and portals with submission and approval data. Handle deviations, CAPA tracking, and documentation per internal quality procedures. Required Qualifications: Bachelor s or master s degree in pharmacy, Life Sciences, or related field. 5+ years of experience in Regulatory Affairs, preferably in international or outsourced settings. Strong understanding of regulatory submission processes and lifecycle management. Familiarity with regulatory tools such as Veeva Vault RIMS and...

What Will You Do: Assess regulatory intelligence for supporting development of local, regional, and global regulatory strategies. Evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle to ensure product compliance and anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions. Assist in the development of regulatory strategy and update strategy based upon regulatory changes. Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities. Provide regulatory information and guidance for product development and pla...

Role and Profile: AGM / DGM Liaison and Corporate Affairs Exp 12-20 Years Location: Gurugram HR Role Objective : Manage sanction and approval process of company's real estate projects including Residential group housing, Plotted Developments, Commercial, Hospitality, Mixed Land Use Project, Liaise with various Govt. Depts. and local statutory bodies including to DTCP, TDP, GMDA, HUDA, other Urban Development Authorities, Municipal Corporations, Pollution Control Board, SEAA, SEIAA, MOEF, DC Office etc. Key Job Role & Profile: Managing Revenue Records documentation, scrutinise land documents and advise for corrections required Preparation, Submission and Follow-up of Licence Application / CLU...

Lead and manage our US company’s regulatory portfolio, with a focus on biocides and other regulated products Work directly with EPA, PMRA, and other regulatory agencies to obtain new product registrations and maintain existing ones Required Candidate profile Regulatory Chemist to join our R&D and regulatory team at our R&D lab in India and working for US regulatory. Managing our US regulatory portfolio, focus on biocides and related product registrations.

Description Regulatory Manager (CMC, EU & Japan/China) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem so...

Description Regulatory Manager (CMC, EU & Japan/China) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem so...

SUMMARY Purpose of Job: Support the effective management of company assets throughout their lifecycle, ensuring accuracy, accountability, and compliance. The role focuses on maintaining updated asset records, monitoring utilization, and assisting in the reconciliation of fixed and movable assets. The position is responsible for providing timely and accurate asset-related data to management; assisting in audits. Job Description: Through Google Sheet operate CAPEX PR & PO. Maintain equipment details. Maintain vendor service PO. It is maintained totally through Google Sheet with a variety of reports. Good knowledge of Excel, Word & PowerPoint. Requirements Required relevant experience (Type and...

What youll do: Manage the end-to-end Medical, Legal, and Regulatory (MLR) review process for promotional and non-promotional content submissions. Prepare and submit materials into review platforms (e.g., Veeva PromoMats ), ensuring metadata accuracy, reference linking, and version tracking. Coordinate with content creators, brand teams, legal, and medical reviewers to schedule review meetings and ensure timely feedback. Track review outcomes, manage revisions and resubmissions, and escalate bottlenecks or delays as needed. Ensure compliance with internal SOPs, regulatory guidelines (e.g., FDA, EFPIA, ABPI), and therapeutic-specific mandates. Maintain and update MLR trackers, dashboards, and ...

Job Title: Executive FRD Non Orals Business Unit: R&D1 Regulatory Affairs Job Grade G12A Location Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own SunshineAs you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Job Description To design and conduct experiments for preformulation, for...

Manage and coordinate international shipping operations for timely and efficient delivery. Develop and implement logistics strategies to optimize costs and reduce delays. Collaborate with cross-functional teams to resolve operational issues and improve processes. Analyze shipping data to identify trends and areas for improvement. Ensure compliance with regulatory requirements and industry standards. Coordinate with suppliers and vendors to negotiate rates and services. Job Requirements Proven experience in international shipping operations or a related field. Strong knowledge of logistics, transportation management, and supply chain management. Excellent analytical, problem-solving, and comm...