3208 Regulatory Affairs Jobs - Page 26

HA (Health Authority) submissions and regulatory compliances for New Drugs, Line extension, additional indication, production transfer, site registration, renewal, CMC, PI, PSUR to ensure business continuity and support clinical trial projects under GDO and need-based support to other regulatory projects in CPO India To oversee and drive compliance activities within CPO and ensuring maintenance of the same as per stipulated timeline, About The Role Key Responsibilities Compilation and HA submissions of New Drug applications, Line extensions, additional indications along with the site registrations, renewals and production transfer applications for Novartis Pharma products and demonstrate ind...

URGENT OPENING FOR REGULATORY AFFAIRS OFFICER/ SR OFFICER LOCATION VADODARA Position:-Regulatory Affairs Officer/ Sr Officer Location:-Vadodara Experience:-1 to 3 Yrs (Formulation) Qualification :- B.Pharm/ M.Pharm Required Candidate profile Preparing dossiers as per country-specific guidelines. Compiling and reviewing documents. Coordinating with QA for documentation. Addressing queries raised by respective countries' FDA.

Company Overview: Lifenity Health Limited is a value-driven organization was evolved in 2012 with an aim to introduce wellness to infinite lives. We are one of the leading providers in the field of preventive and diagnostic health care solutions globally. We have the latest infrastructure, innovative technology, accreditation and pool of experts in health care, IT, and data analyst professionals to easily execute mass screening, diagnostics, and healthcare analytics which is acknowledged by eminent hospitals, healthcare professionals, and government bodies. Vision: To provide optimum health & wellness across the lifespan, of the population we serve. Mission: To provide quality diagnostic & h...

As a Regulatory Affairs Specialist at Apotex Inc., you will be responsible for managing the product life-cycle of Apotex products in identified markets. Your duties will include maintaining documentation/database records, leading regulatory affairs projects, and preparing submission and approval notifications for applications submitted to Regulatory agencies. Key Responsibilities: - Provide support and regulatory guidance to a team in completing projects supporting regulatory submissions. - Prepare and review quality regulatory PLCM submissions for various markets to ensure timely approval. - Maintain and complete regulatory documents to support regulatory compliance in various markets. - As...

As a Regulatory Affairs Director at Azurity Pharmaceuticals, your role involves ensuring the development and implementation of effective regulatory strategies for projects in development and approved. You will be responsible for providing regulatory guidance, requirements, and strategy for assigned projects to internal and external stakeholders, as well as leading the execution of regulatory strategies for pre-approval and post-approval activities. Your oversight of regulatory team activities will include managing filings, conducting technical reviews of documents, and ensuring regulatory compliance. - Develop and implement robust regulatory strategies and plans for projects, ensuring regula...

**Job Description:** As the Program Manager for the Patient Oriented Program (POP), your primary responsibility will be to oversee and manage all activities related to POP, ensuring compliance with the applicable process and quality standards. You will collaborate with cross-functional teams to ensure the successful execution of the POP. **Key Responsibilities:** - Administer the end-to-end POP process on behalf of the Business Owner (BO) following the Doing Business Ethically (DBE) policy and POP Standard Operating Procedures (SOP). - Coordinate with all POP stakeholders (POP Champion, Procurement, Legal, Patient Safety, Compliance, Quality Assurance) to create POP documents. - Obtain neces...

Job Description As a Manager Legal at ideaForge, a listed leader in the drone industry, you will be responsible for managing and driving the legal function with a sharp focus on business enablement, compliance, and governance. This role requires an experienced legal professional with proven expertise in managing end-to-end complex contractual negotiations and closures, ensuring adherence to regulatory requirements, and safeguarding the company's interests while enabling strategic growth. The position demands a proactive leader who can anticipate risks, balance business objectives with legal safeguards, engage effectively with senior management, regulators, investors, and law firms, and ensur...

Job Title: Quality Head Sudhir Srivastava Innovations Private Limited Location: Udyog Vihar, Phase-III, Gurgaon, Haryana Employment Type: Full Time Relevant Experience: 7+ Year's Salary: As per the Industry Standard Position Summary: SSII, an US based medical devices company engaged in developing and manufacturing class II & III Surgical Robots is seeking a Head Quality for its Gurgaon, India location. Join an organization with a passion for commercializing smart, effective and patient centric Robotics solutions. The Head of Quality is a key member of the site Leadership Team, and this role leads the SSII Quality and Quality System functions in India. This role will be a critical leader of a...

As a Clinical Research Trainer at PMCTI, your role involves delivering training sessions on Clinical Research, GCP (Good Clinical Practice), Regulatory Affairs, Pharmacovigilance, and related topics. You will be responsible for designing, updating, and improving training materials, presentations, and assessments. Assessing and evaluating trainees" understanding through tests, assignments, and practical exercises will also be a key part of your responsibilities. It is essential to stay updated with the latest industry trends, guidelines, and regulatory changes to ensure the quality of training sessions. Conducting both classroom and online training sessions as per company requirements and pro...

Assist in planning, initiation, monitoring, and completion of clinical trials. Conduct site qualification, initiation, routine monitoring, and close-out visits. Ensure all trial activities are conducted according to protocol, SOPs, GCP, and applicable regulatory guidelines. Verify that clinical data is accurate, complete, and verifiable from source documents. Maintain essential documents and track trial progress in the Trial Master File (TMF). Support communication between sponsors, investigators, and site staff. Identify and resolve issues that arise during study conduct. Ensure subject safety and proper reporting of adverse events (AEs/SAEs). Prepare visit reports and follow-up letters as ...

Responsibilities : Monitor newswires, newspapers, and company websites to gather information and news articles about the financial sector and companies under our coverage. Provide timely, insightful news blurbs and insightful articles in English to tight daily andweekly deadlines Cover news by incorporating in-depth interviews, conference coverage, proprietary data and analytical insights Collaborate with our Data Journalists to incorporate data into stories, driving our news beyond the headlines Collaborate with our Production team to craft creative infographics and visuals What were looking for: Basic Qualifications: Solid background in writing and keen eye for details Able to work well un...

Job Title: Validation Specialist Job Grade: G11A/ G10 Function: Global Information Technology Sub-function: Manufacturing & Quality IT Manager’s Job Title: Validation Lead Skip Level Manager’s Title: Head SGO IT India Function Head Title: Global Chief Information Officer Location: Mohali Areas Of Responsibility 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 charg...

About The Role Project Role : Technology Consulting Practitioner Project Role Description : Advises, leads and works on high impact activities within the systems development lifecycle, and provides advisory work for the IT function itself. Must have skills : Oracle Utilities Customer to Meter C2M SPL Good to have skills : SQL Minimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Technology Consulting Practitioner, you will engage in high-impact activities throughout the systems development lifecycle. Your typical day will involve advising and leading teams, collaborating with various stakeholders, and providing strategic insights t...

About The Role Project Role : Technology Consulting Practitioner Project Role Description : Advises, leads and works on high impact activities within the systems development lifecycle, and provides advisory work for the IT function itself. Must have skills : Oracle Utilities Customer to Meter C2M SPL Good to have skills : NA Minimum 2 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Technology Consulting Practitioner, you will engage in high-impact activities throughout the systems development lifecycle. Your typical day will involve advising and leading teams, collaborating with various stakeholders, and ensuring that the IT function a...

Job Title: Clinical Product Owner/Scientist Location: Bangalore Experience: 10+ years Role Overview: We are seeking a visionary and accomplished Medical Device Clinical Product Owner to lead our new product development initiatives in Healthcare and Life sciences. This role combines deep functional expertise with strong leadership and business acumen. The ideal candidate will have a proven track record in conceptualizing, evaluating, and developing medical systems. You will liaison with medical practitioners, OEM partners and cross-functional engineering teams to guide solution development and implementations. This is a customer-facing role with a strong focus on innovation, solution developm...

Position: Senior Regulatory Affairs Manager Global Cosmetics Compliance Department: Regulatory Affairs / Operations Reports to: COO (Integrator) & CEO Location: India, Noida- Sec- 63 Employment Type: Full-time Shift Time- 12 PM IST- 9 PM IST About CBAYEXPRESS / Herbishh: CBAYEXPRESS CORPORATION is a Canadian-based e-commerce company selling across Amazon (US, CA, MX, UK, EU, AU, SG, IN, UAE), Walmart, Shopify (Herbishh.com, BisonBody.com), eBay, and other marketplaces. Our flagship brand Herbishh is a leader in haircare and beauty, with rapid global expansion. With $15M+ annual revenue, we are scaling towards $30M+ globally, and compliance is a key pillar of our success. Role Overview: We ar...

Key Responsibilities Monitor and manage IT support queues, ensuring timely triage and resolution of incidents and service requests Respond to and resolve incoming support calls and tickets, providing first-line technical assistance to end users Troubleshoot basic network issues such as connectivity problems, access-point availability, and switch-port configurations Assist in identifying and resolving issues related to firewall rules or access restrictions in collaboration with the network/security team Process and fulfil endpoint hardware requests in line with company standards and asset-management procedures Ensure adherence to Service Level Management (SLM) procedures, escalating issues wh...

Position: Financial Reporting & Consolidation Lead Designation: Senior Manager / Assistant General Manager Function: Finance & Accounts Place: Guwahati (RO), Assam Credentials: Chartered Accountant Responsibilities: • End-to-end responsibility for ensuring accurate, timely, and compliant financial reporting and consolidation across all business units and subsidiaries within the region • Oversee statutory financials, consolidation, internal reporting, and ensure adherence to accounting policies and governance standards • Prepare and review standalone and consolidated financial statements (Balance Sheet, Profit & Loss Statements) • Ensure timely closure of books (monthly / quarterly / annual) ...

Responsible for compilation and assist team for projects and regulatory submissions by collating documents per regulatory requirements for Europe and UK market for CMC and labelling aspects. To collate and compile new application & life cycle management CTD dossier modules from M1 to M5 for Europe and UK. Interpret and prepare response to the quality & administrative deficiencies as per regulatory requirement within defined timelines. Develop and implement regulatory CMC strategies to support new MAA and post-approval changes (PACs), variations, and life cycle activities. Co-ordinate with cross functional teams for document request, review, required for regulatory submission. Upload and publ...

Walk-In Drive For Regulatory Affairs - FML Department in FML Division - MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Saturday 18-10-2025. Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs - FML Division ) Should have minimum of 03 to 08 years of experience in FML Regulatory Affairs Job Title : Executive / Senior Executive / Junior Manager Experience : 03 to 08 years in FML RA field Education: B Pharm \ M Pharm Department : Regulatory Affairs - FML Roles & Responsibilities : Collect documents from various departments to prepare regulatory submissions. Prepare regulatory submissions to relevant authorities. Prepare amendments, updates, and re...

Role : Company Sectorial & Compliance Officer Qualification : LLB,CS Experience : 4 to 8 Years Location : Andheri East Job Description : we are seeking a qualified and experienced Company Secretarial & Compliance Officer to lead our corporate compliance and secretarial function at the Mumbai office. Given the current listing suspension, we require someone with strong regulatory experience and active engagement with SEBI, NSE, and BSE. The ideal candidate will have over 4 years of listed company experience, with current employment in a listed entity, and be capable of managing high-stakes corporate compliance and governance processes. Key Responsibilities: Corporate Compliance & Regulatory Af...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Role Summary The QARA Director for India will be responsible for leading a team supporting Quality Assurance and Regulatory Affairs activities in India. This leadership role is responsible for developing and executing regulatory strategies and maintaining quality related activities and systems to ensure compliance with Indian and international medical device regulations (e.g. CDSCO, ISO 13485/Indian GMP, US FDA, EU MDR). The QA/RA Dire...

FSSAI Compliance Licensing Manage Central/State FSSAI license applications, renewals, and modifications Maintain accurate records of licenses and related documentation Coordinate inspections and audits with internal teams and consultants Formulation Compliance Review Review formulations and ingredients for compliance with FSSAI, nutraceutical, and international standards Ensure ingredient limits, claims, labeling, and nutritional facts meet regulatory guidelines SOI (Schedule of Ingredients) Management Prepare and maintain SOIs for all finished products Verify raw materials against approved regulatory lists Documentation Record Keeping Maintain regulatory master files for all products and SK...

In your capacity as a Regulatory Medical Writer, you will focus on crafting compliant medical documents that meet the rigorous standards of health authorities and regulatory bodies. You will also be responsible for maintaining a strong knowledge of medical terminology, guidelines, and regulations to ensure the accuracy and quality of all content produced. In addition, you must stay up to date on industry trends and best practices in medical writing and content creation, continuously improving and evolving our strategies to meet the changing needs of our partners. Your expertise and dedication to producing high-quality content will help us deliver impactful and relevant materials that resonat...

Role & responsibilities Prepare, review and submit regulatory documents for new drug applications, product registrations, amendments and renewals to the US, Brazil, EU, India and State Level authorities. Regulatory Submissions : Prepare and submit regulatory documents, including INDs (Investigational New Drug Applications) and NDAs (New Drug Applications) to regulatory authorities. Compliance and Licensing: Ensure compliance with regulatory requirements of US, Brazil, EU & India. Liaise with regulatory authorities for drug licensing, including product registrations, renewals and manufacturing licenses for local and international markets. Ensure timely submission of import licenses and NOcs (...