2122 Regulatory Affairs Jobs - Page 38

As a Senior Chemist in the Pharma Manufacturing Industry based in Vatva, Ahmedabad, you will be responsible for the synthesis of APIs and intermediates. Your role will involve conducting feasibility studies, selecting synthesis routes, and implementing multi-step synthesis processes to improve yield and reduce costs. You will utilize your expertise in conducting literature searches using platforms such as SciFinder, Chemical Abstracts, and Free Patent Online, as well as referring to various journals. Additionally, you will be involved in extraction, purification, and distillation processes, along with conducting lab validations. Strong documentation skills are essential for this role, includ...

You will be joining USV Private Limited, a leading pharmaceutical company in India known for its expertise in the diabetes and cardio sectors, with a global presence in over 65 countries. Your role will be in the Biologics function, specifically as an Assistant Manager or Manager in Regulatory Affairs (Clinical Trials) focusing on the EU and US markets. You will be based in Govandi (East), Mumbai, with a work schedule that includes working on the 1st, 3rd, and 5th Saturdays, while having the 2nd and 4th Saturdays off. To be considered for this position, you should have a qualification of M.Pharm/B.Pharm along with 5-15 years of relevant work experience in Regulatory Affairs-Clinical Trials f...

Job Summary As a Sr. Consultant specializing in Devices you will play a pivotal role in driving innovative solutions and strategies for our clients. With a hybrid work model and day shifts you will collaborate with cross-functional teams to enhance device-related processes and outcomes. Your expertise will contribute to the companys mission of delivering cutting-edge technology solutions that positively impact society. Responsibilities Lead the development and implementation of device strategies to optimize client outcomes and enhance operational efficiency. Oversee the analysis of device-related data to identify trends and opportunities for improvement. Provide expert guidance on device sel...

JOB PROFILE OF SR. TECHNICAL OFFICER-QUALITY ASSURANCE MENDINE PHARMACEUTICALS PVT LTD Job Title / Designation- SENIOR TECHNICAL OFFICER - QA Qualifications- M.PHARM Experience- 5 to 6 years experience in QUALITY ASSURANCE Job Objective- The ideal candidate will be responsible for implementing and maintaining quality systems, ensuring compliance with cGMP guidelines, conducting internal audits, reviewing batch records, and supporting regulatory inspections. This role demands strong documentation skills, a sound understanding of pharmaceutical quality standards, and the ability to work collaboratively across departments to uphold product integrity and safety throughout the manufacturing proce...

Sr.Manager Compliance L6, Target Plus (T+) Target is an iconic brand, a Fortune 50 company, and one of Americas leading retailers.Alongside Targets distinctive retail presence, our digital footprint is rapidly evolving to deliver a world-class online shopping experience. If you thrive in a fast-paced environment and are passionate about retail innovation, youll find success in Target Plus , Targets curated third-party marketplace. Here, youll collaborate to shape digital strategies that support scalable growth and drive operational excellence for our sellers and guests.You will play a critical role in ensuring adherence to all relevant regulatory requirements and product safety standards. Th...

If your location allows for pay/benefit transparency, please click the link below to request further information on this position. Pay Transparency Request Form This position is 100% remote. PURPOSE AND SCOPE: Responsible for leading the strategic direction and execution of regulatory strategies for our global pharmaceutical portfolio. This position plays a critical role in influencing regulatory decisions, managing complex global submissions, and ensuring successful product development, approval, and market access for FME s product portfolio. The Global Strategy Leader will work closely with internal and external stakeholders to align regulatory strategies with business objectives and drive...

Rama Super Speciality Hospital is looking for ENT Surgeon to join our dynamic team and embark on a rewarding career journeyExamining patients to diagnose and evaluate their medical conditions, including the use of diagnostic equipment and tests such as X-rays and MRI scans.Developing and implementing treatment plans, including the use of surgical procedures and other medical therapies.Performing surgical procedures to treat conditions such as ear infections, hearing loss, sinusitis, voice and speech disorders, sleep apnea, and head and neck tumors.Communicating with patients and their families, discussing diagnoses and treatments, and answering questions and concerns.Collaborating with other...

Prepare and submit regulatory dossiers for product registrations, import licenses, and amendments to the CDSCO. Maintain up-to-date knowledge of Indian medical device regulations (Medical Device Rules, 2017 and amendments). Liaise with CDSCO, state licensing authorities, and third-party regulatory consultants. Support Quality Assurance in audits, product recalls, and field safety corrective actions. Ensure compliance with India-specific labeling, documentation, and advertising regulations. Monitor and assess changes in regulatory guidelines and communicate impact to cross-functional teams. Maintain regulatory files and tracking systems for timely renewals and updates. Collaborate with global...

Project Role : Tech Delivery Subject Matter Expert Project Role Description : Drive innovative practices into delivery, bring depth of expertise to a delivery engagement. Sought out as experts, enhance Accentures marketplace reputation. Bring emerging ideas to life by shaping Accenture and client strategy. Use deep technical expertise, business acumen and fluid communication skills, work directly with a client in a trusted advisor relationship to gather requirements to analyze, design and/or implement technology best practice business changes. Must have skills : Environment Health and Safety Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : BE o...

Seeking for experienced & strategic Regulatory Affair leader. will oversee all regulatory submission activities, maintain compliance with evolving global health authority requirements & provide expert regulatory guidance for pharmaceutical products

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...

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 ...

Role & responsibilities * Data Entry and Updation in Regulatory Information Management System. * Dossier preparation (New/ Renewal/ Variations) for different countries. * Other RA Related Activities. Perks and benefits * 5 days working Environment * Additional Benefits.

Note: Qualification: B.Tech / B.E. in Biomedical Engineering, Biotechnology, or related Medical Engineering field (Pharma background (B. Pharma / M. Pharma) profiles will not be considered) Mandatory Skills: Regulatory Affairs Medical Devices EU MDR compliance Design History File (DHF) Risk Assessment & Risk Management Familiarity with ISO 13485 and other applicable standards Key Responsibilities: Prepare, review, and manage regulatory submissions for medical devices (India and international markets) Ensure compliance with EU MDR (Medical Device Regulation) and local regulatory requirements Maintain and update Design History Files (DHF) , Technical Files, and Risk Management documentation Co...

Senior Manager Job Role Process designing for Credit Cards covering key aspects of Process Workflows (Digital Physical), Compliance, Risk, Legal, Ops, Customer Experience, etc. Creating and documenting SOPs/Process notes of various Credit Card processes with clear defined roles and responsibilities to promote efficient implementation. Ability to think through end to end process at various touchpoints such as online channels, partners, Branches, Call center etc. Review processes in light of Fraud and Risk raised by RCU and ORM. Identification of Risks and Regulatory breach on cards processes and provide solution to mitigate risks and control reports to minimize process lapses. Monitor and gov...

We are looking for a highly skilled and experienced Field Risk Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-5 years of experience in the BFSI industry. Roles and Responsibility Conduct risk assessments and evaluations to identify potential threats to the organization. Develop and implement effective risk management strategies to mitigate identified risks. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Analyze market trends and competitor activity to inform business decisions. Identify and report on key performance indicators (KPIs) to senior management. Provide expert guidance on risk management best p...

Location: Wegmans Business Park ( Greater Noida) Exp 2 to 5 years Excellent Writing and Spoken English required Monday to Saturday - Critical Minerals Domain About the Role We are seeking an experienced individual to join our team as the Member of Public Affairs. In this key role, you will be responsible for shaping and executing our policy & government relations strategy, enabling us to navigate the complex regulatory landscape, secure government incentives, and foster positive relationships with key stakeholders. Responsibilities Advocacy : Lead efforts to advocate for client with government bodies and industry stakeholders. Foster relationships with key officials, monitor policy changes, ...

As a highly organized Cybersecurity Officer at AmeriPharma, you will play a crucial role in managing system-wide healthcare compliance, information security, and privacy regulations. Reporting to the Director of Regulatory Affairs, you will be responsible for ensuring regulatory excellence, information security, and adherence to federal and state laws. Your primary focus will be on fostering a culture of accountability, trust, and risk management across all IT infrastructures. Your duties will involve developing and managing a comprehensive cybersecurity program in compliance with regulations such as HITECH, providing cybersecurity support during software and network development, conducting ...

Jubilant Pharma Limited is a global integrated pharmaceutical company that offers a wide range of products and services to customers across various geographies. The business is organized into two segments: Specialty Pharmaceuticals and Generics & APIs. Specialty Pharmaceuticals segment includes Radiopharmaceuticals, Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products. Generics & APIs segment comprises Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly-owned subsidiary of Jubilant Pharma with Research & Development units in Noida and Mysore, India. It operates two manufacturing facilities in Mysore, Karnataka, an...

The position of Manager is open in the Global Regulatory Affairs Specialty Pharma department. As a Regulatory CMC Product team member, you will provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded products being developed for the US and other advanced markets like EU & Canada. Your responsibilities will include ensuring lifecycle management by submitting annual reports and supplements in a timely manner to ensure product continuity. You will be accountable for the delivery of all regulatory milestones for higher complexity products, including assessing the probability of regulatory success and implementing risk mitigation measures. In thi...

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. The business is organized into two segments: Specialty Pharmaceuticals and Generics & APIs. Jubilant Generics (JGL), a wholly-owned subsidiary of Jubilant Pharma, operates Research & Development units in Noida and Mysore, India. The company has two manufacturing facilities - one in Mysore, Karnataka, and another in Roorkee, Uttarakhand - engaged in the production of APIs and Dosage manufacturing. The Mysore manufacturing location, spread over 69 acres, is a USFDA approved site specializing in manufacturing APIs for Lifestyle driven Therapeu...

You will be working as a full-time Regulatory Compliance Manager based in Delhi, India. Your primary responsibility will be to ensure the company's compliance with SEZ, Custom (MOOWR, AEO, SVB), DGFT, and FSSAI regulations. This involves obtaining permissions from Custom, implementing compliance mechanisms for MOOWR and AEO with Custom authorities, and liaising with Custom and SEZ authorities to secure necessary approvals for clients of Laureate in a timely manner. To excel in this role, you should possess a strong understanding of regulatory compliance and requirements, particularly in Custom and SEZ domains. Your tasks will include obtaining permissions from DGFT authorities for Advance Au...

The position requires you to deliver excellent business results through your team's efforts. Your responsibilities include utilizing writing skills to create adverse event and product complaint narratives during intake and developing custom responses for medical inquiries. You will handle requests through various channels such as phone, email, CRM, and chat. It is crucial to identify adverse events and product complaints during customer interactions, accurately generate reports, and adhere to regulatory procedures. You will coordinate processes to address product quality-related complaints by collaborating with departments like Quality Assurance and Regulatory Affairs. Maintaining knowledge ...

The Manager in the Global Regulatory Intelligence team is a hands-on contributor responsible for gathering and organizing regulatory intelligence under the guidance of the RI Director. This role often has a technology and data focus , managing the tools and information that drive the intelligence process. Key Responsibilities: Intelligence Gathering & Analysis: Assist in monitoring and analyzing the global regulatory landscape, and in developing intelligence reports and updates as directed by the RI Director. A core duty is to collect and synthesize new or updated local regulatory requirements obtained from Amgen s local regulatory teams, for the Manager s assigned areas of responsibility. T...

To study the Transactional compliance Plan for every project and document the list of applicable Regulations and Standards Preparation of Compliance documents for specific projects with list of impacted items from the TRS Matrix Work with the suppliers to ensure that the parts / assemblies manufactured by them meet the compliance requirement of the project Collect and compile the documents / certificates for the project and upload the central repository Work with Design team on regular basis and initiate the improvement actions Adopt the best practices from other business and incorporate Schedule the meetings with other teams to ensure compliance is met