2119 Regulatory Affairs Jobs - Page 7

Job Title: Manager-2 - FR &D Non-Orals (Compliance group) Business Unit: R&D1 Regulatory Affairs Job Grade G11A 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 Sunshine? As 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 Review documents required for ...

1. Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other domestic markets. 2. Support product development, registration, & lifecycle management in Europe 3. Manage Regulatory Compliance & Approvals Required Candidate profile 1. Minimum 4 years of exp in Formulation OSD 2. Willing to work in Chennai 3.Strong expertise in EU, EMA, MHRA & other international regulatory framework 4. Exposure in domestic regulatory market

As a Compliance Officer at the NBFC, your role involves ensuring regulatory compliance and maintaining effective communication with regulators. You will be responsible for various key activities: - **Regulatory Liaison**: - Act as the Single Point of Contact (SPOC) between the NBFC and regulators such as RBI, CICs, and Ombudsman. - Handle all official communications and queries from the RBI regarding inspections, audits, and compliance matters. - **Grievance Redressal**: - Receive, record, and address customer complaints in line with RBI Fair Practices Code. - Ensure timely resolution of complaints within regulatory timelines. - Prepare periodic reports on grievance status for submission to ...

As a Product Packaging & Artwork Specialist at Janitri, you will play a crucial role in developing packaging solutions and coordinating artwork for our innovative medical devices. Your attention to detail and collaboration with cross-functional teams will ensure that the final deliverables meet brand, functionality, and compliance standards effectively. **Key Responsibilities:** - Develop primary and secondary packaging for product SKUs in alignment with product dimensions, protection needs, and branding guidelines. - Prototype and test packaging solutions, iterate based on feedback, and real-world performance in coordination with the production team. - Coordinate with the regulatory affairs...

As a Cosmetic Regulatory Affairs Assistant at our company in Jodhpur, you will play a crucial role in ensuring that our cosmetic products meet all regulatory requirements and standards. Your attention to detail and proactive approach will be essential in supporting the Regulatory Affairs department. Key Responsibilities: - Ensure compliance with all relevant regulatory standards and guidelines. - Monitor changes in legislation and the regulatory environment, and take necessary actions. - Assist in collecting and reviewing raw material documents. Qualifications & Skills: - Bachelor's degree in Pharmacy, Chemistry, Cosmetic Science, or a related field. - Previous experience in regulatory affai...

You will be responsible to review of journals and patents. You will be responsible for feasibility study of the Process, Process Optimization,Lab Validations, Technology Transfer to plant and identify and evaluate the reaction parameters You will be responsible for staying up to date with relevant scientific and technical developments. Execute experiments efficiently with high reproducibility. You will be responsible for interpretation of analytical and spectral data to ensure quality and regulatory compliance. You will be responsible to write technical development reports, Quality by Design (QbD) reports, justification reports and Drug Master Filing (DMF) filing related documents. You will ...

Veeva Vault-RegulatoryOne Administrator: The Veeva Vault-RegulatoryOne Administrator oversees the maintenance, development, implementation and roll-out of Veeva RegulatoryOne for UPL Regulatory Affairs. RegulatoryOne is the application used by Regulatory Affairs team to manage regulatory data and documents to run regulatory activities primarily. UPL adopted RegulatoryOne globally in 2022 and is continuously extending the scope and features. Our objective is to leverage RegulatoryOne for the benefit of other functions such as Marketing or Supply Chain by integrating with their IT applications (ERP, CRM, etc.). The focus for the next 12 months will be on dossier management (binders), document ...

Min 6yrs of experince in Regulatory affairs, CMC. US market exp must location Bachupally, Hyderabad

Job Summary: We are looking for an experienced and strategic Regulatory Affairs leader to head our Regulatory function. The ideal candidate will oversee all regulatory submission activities, ensure timely approvals, maintain compliance with evolving global health authority requirements, and provide expert regulatory guidance for new and existing pharmaceutical products across ROW & regulated markets. Key Responsibilities Regulatory Strategy & Compliance: • Coordinate with agents, partners, and MOHs to define submission strategies. • Prepare internal strategy documents and lead regulatory discussions for new products. Dossier Management & Submissions: • Manage CTD/ACTD/eCTD submissions for ne...

Roles and Responsibility Develop and implement operational strategies to achieve business objectives. Manage and supervise a team of professionals to ensure efficient operations. Analyze operational data to identify areas for improvement and optimize processes. Collaborate with cross-functional teams to align with organizational goals. Ensure compliance with regulatory requirements and industry standards. Foster a culture of continuous improvement and excellence within the team. Job Requirements Proven experience in operations management with a minimum of 8 years of experience. Strong leadership and management skills, with the ability to motivate and inspire teams. Excellent analytical and p...

Manage release of product batches, including owning the QA product release workflow in SAP. Lead and supervise a team of QA professionals to perform operations as described above. Review and approve Purchase Specifications

This position is Canada Overseas recruitment. The person will be deployed in Agriculture farms for the help. Tractor driver They will work like a farmers there. Process will take around one year. The Person have to clear the IELTS test.

Role & responsibilities Regulatory Compliance: Monitor and ensure adherence to legal, regulatory, and company policies. Responsible for ensuring that the company complies with all external regulatory requirements and internal policies and procedures. Assisting the legal department to communicate the associated statutory requirements with every applicable Industrial, Labour and Environmental regulatory and legal compliance. Internal Policies & Procedures : Develop, implement, and enforce internal compliance policies and procedures. Conduct regular compliance audits and assessments to ensure policies are followed. Reporting and Documentation: Prepare compliance reports for senior management an...

Dear Candidate, Greetings !!!!Thanks for your mail please find the below JD for the position of AVP Planning & Regulatory Position : AVP Planning & Regulatory Location : Gurgaon Compensation : Very Competitive Qualification : Graduation Experience : 20 Years Company: One of the Listed Real Estate Company Below is the JD : AVP Planning & Regulatory Person should be well versed with the Haryana and Punjab licencing / Compliance and approvals process. Should be aware of the various policies and Acts related to the same. Should be capable of drafting letters to the Government ( very important). Should have knowledge of calculations of Govt Fee & Charges / Bank Guarantees etc. Should be able to h...

Role & responsibilities Labeling Responsible for creating and updating compliant English product information for EU procedures. Providing instructions and guidance to local RA (e.g. calculations due to new excipients warnings). Discussion of the content of product information for innovative products (pre- and post-approval) in project teams. Evaluate and approve change requests; coordinate submissions with EU regulatory units. Collaborate on patent-related issues with Global IP Group. Contribute to readability studies and ensure PIL readability and compliance with legal requirements. Adaption to reference medicinal product (generic, hybrid, biosimilar procedures). Preparation of Expert state...

Area Of Responsibility - To review quality and manufacturing end data for various in-house developed APIs for regulatory adequacy for compilation of Drug Master Files/Registration Dossiers, Amendments/Variations, Technical Data Package/Open Parts of DMFs for In-House developed APIs and their updation to meet current regulatory requirements. - To review outsourced intermediates and APIs for regulatory adequacy to support Procurement Team in vendor selection and DF-Regulatory for ANDA/MA submission. - To coordinate & support Chemical Research Department, Analytical Department and Manufacturing locations in generating data as per the requirements of regulatory agencies for regulatory submission...

Greetings from People First Consultants Hiring for a Regulatory Affairs Specialist with a leading medical device manufacturing company! Experience : 2-6 years Notice Period: Immediate - 1 month preferred Location : Bangalore Industry : Medical device manufacturing We are looking for a detail-oriented Regulatory Affairs Specialist with hands-on experience in regulatory documentation and submissions for Class IIb medical devices. You will ensure compliance with CE (EU MDR), USFDA, ISO 13485, and CDSCO MDR-17 standards. If you are open to exploring new opportunities, Kindly share your updated resume at vijayalakshmi@peoplefirst.co.in / WhatsApp at 9566177747 Looking forward to your response. Be...

Experience: 47 years Education: Bachelors degree in Engineering (Electrical, Mechanical, or Renewable Energy preferred) Role Summary We are seeking an experienced Senior Manager Renewable Energy Projects to lead solar and wind project execution. The role demands expertise in project delivery, procurement, compliance, and stakeholder engagement. Key Responsibilities Lead execution and commissioning of utility-scale solar and wind projects across multiple sites Oversee daily project operations, ensuring on-time, on-budget, and safe delivery Manage procurement activities including vendor evaluation, negotiations, and logistics Ensure compliance with all central and state-level permits and regul...

Company Description Alpine Health is a licensed pharmaceutical distributor based in Secaucus, New Jersey, USA. We serve independent pharmacies across the US. Alpine Health offers a full range of generics,OTC's, diabetic supplies, vials and nutritional milk.The organization is in business in the USA market since 2008 and is now expanding its reach of partnering with companies worldwide to introduce high quality medical devices in markets worldwide. Job Description Overview: This is an opportunity to work in a key role with a broad spectrum of responsibilities in a growing healthcare company that has expanded in various domains in the industry and to contribute to the growth of the company. Th...

As a Jr. Officer to Sr. Officer at our company, you will be responsible for the following: - Preparation of dossiers and documents in compliance with CTD, ACTD, and country-specific guidelines. - Reviewing dossiers, DMF, and technical documents. - Addressing queries raised by regulatory authorities. Qualification Required: - Must have an M.Pharm degree. The work location for this position is in Jarod, Vadodara, Gujarat. Additionally, we offer benefits such as health insurance, leave encashment, life insurance, paid sick time, and provident fund. Please note that this position requires a long-term association agreement with an incentive scheme for 2-3 years.,

Role Overview: You have the exciting opportunity to join the Global Regulatory Practice group within Securities Services as an Analyst. In this dynamic role, you will partner with the Business to provide comprehensive insights on regulatory changes, interpret their impact, develop execution strategies and client solutions, publish thought leadership, and engage in industry advocacy. Your role will involve supporting the launch of critical regulatory impact assessment processes, maintaining regulatory governance models and controls frameworks, and supporting client-facing regulatory intelligence tools. You will have cross-regional exposure to different product areas within Securities Services...

As a Regulatory Executive within the D3I department in Bangalore at L'Oral, your role is crucial for ensuring compliance and strategic management of raw material dossiers for innovative beauty products. Your responsibilities include: - **Regulatory Intelligence & Compliance:** Stay updated on global and local regulations, guidelines, and best practices related to raw material dossier management. - **Dossier Management:** Take ownership of assigned raw material regulatory topics, meticulously building and managing comprehensive raw material dossiers to meet specific regulatory scopes and requirements. - **Stakeholder Management:** Effectively manage relationships with internal teams and exter...

What You Will Do Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Viewed as regulatory team resource. Usually works with minimum supervision having some latitude for independent action or decis...

Education: Bachelors in Engineering, Renewable Energy, or Business Management (Masters preferred) Role Summary We are seeking a visionary General Manager Renewable Energy Projects to lead our solar and wind portfolio. The role requires a proven leader with experience managing large-scale infrastructure projects end-to-end. Key Responsibilities Lead the full lifecycle of solar and wind projectsfrom planning and procurement to execution and O&M Ensure compliance with all permitting and regulatory processes Drive business development and identify growth opportunities in renewables Manage budgets, monitor performance, and optimize resources Build strong relationships with clients, government age...

Job profile Qualification : Bachelors Degree / Master Degree Industry Type : FM Services, Hotels, Projects, Overall Experience : 12 -14 years Industry Experience : 10-12 years of relevant / equivalent experience Technical Skills : Building Services Generic Skills : Leadership, Communication, Vendor/people management, Strategies Behaviors : Team work, Learning attitude, Innovation mindset Job Aim: To take complete ownership for all client deliverables for all the facilities in the city. The person will be responsible to provide comprehensive facility management services, as per the contractual terms with a focus on continuous improvement for the respective facilities. Will also be responsible...