3208 Regulatory Affairs Jobs - Page 19

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorke...

*This position is a temporary requirement for 8 months. Location: Andheri, Mumbai (Hybrid working opportunity) About the Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for a Senior Executive- Regulatory Affairs. What You'll Do: Planning and preparation for Renewals / annual maintenance of MA's assigned; ensure all regulatory requirements of health authorities are met, and supply continuity for the products is maintained. Ensure informing stakeholders (internal & external) and requesting document(s), information sufficiently ahead of time, proactively following up for time...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Responsible for the product life-cycle management of Apotex products (Toronto) ...

We are looking for 3-6 years experienced QA Manager and having worked in Medial Devices / Pharma manufacturing industry, particularly in handling SOP's, DMF, SMF and CDSCO Regulatory approvals , GMP audits, documentation processes. familiar ISO13485 Required Candidate profile Candidates with graduation in molecular biology, B pharmacy with thorough knowledge about DMF,SOPs preparation ,SMF, GMP audits,must know about complete documentation and Quality assurance procedures

Do you want to be part of an inclusive team that works to develop innovative therapies for patients Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. ?If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. Fo...

About Us Friday Plansis a technology-driven US-based company evolving from a leading online pharmacy into a vertically integrated pharmaceutical company. Our mission is to develop, manufacture, and commercialize our own portfolio of medicines for the US market. We are seeking a seasoned regulatory leader to navigate this journey and build our regulatory function from the ground up. Position Summary We are looking for a strategic and hands-on Director of Regulatory Affairs to lead all regulatory activities for our product portfolio targeting the US market. This individual will be responsible for developing and executing the regulatory strategy for our pipeline, from early development through ...

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Regulatory Medical Writer Roche India - Roche Services & Solutions Chennai or Hyderabad A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they...

Company Description Dyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment. Role Description This is a full-time on-site role for a Senior Regulatory Affairs Specialist, located in Hyderabad . The Senior Regulatory Affairs Specialist will be responsible for managing regulatory documentation, ensuring regulatory compliance, overseeing regulatory submissions, and staying updated with regulatory requirements. This role involves coordinating with various departments to ensure all regulat...

Kotak Mahindra Bank Limited is looking for Team Sales Manager-SARAL LOANS-Marketing Branches Operations to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and mark...

Preparation/revision and review of Formulation Orals and finished product specification and analytical test procedure. Preparation/revision and review of excipient and packaging material specification and analytical test procedure. Review for Pharmacopoeial compliance and revision of documents accordingly. Knowledge on excipient analysis and compendial requirements. To support query response activity in case of excipients and finished product. To participate and contribute in achieving operation efficiency and performance execution. To execute all documentation work keeping in view of Compliance and Documentation integrity. Educational Qualification Graduate : M. Sc/M. Pharm Experience

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...

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. Coordinate with various departments to ensure seamless operations and resolve issues. Implement and maintain quality control measures to ensure high standards. Identify and mitigate risks to ensure compliance with regulatory requirements. Job Requirements Proven experience in operations management with a minimum of 5 years of experience. Strong knowledge of operational principles and practices. Excellent leadership, communication, and...

Key Responsibilities: Develop, implement, and maintain robust financial crime prevention policies and procedures, including anti-money laundering (AML), fraud, sanctions compliance, and counter-terrorism financing (CTF). Lead and manage financial crime risk assessments and due diligence processes. Oversee investigations related to suspicious activities, ensuring timely escalation and resolution. Ensure compliance with applicable laws, regulations, and industry standards. Coordinate with internal departments and external regulators on compliance issues. Monitor and report on regulatory changes and implement necessary adjustments. Provide training and awareness programs on financial crime and ...

Preparation/revision and review of Formulation Orals and finished product specification and analytical test procedure. Preparation/revision and review of excipient and packaging material specification and analytical test procedure. Review for Pharmacopoeial compliance and revision of documents accordingly. Knowledge on excipient analysis and compendial requirements. To support query response activity in case of excipients and finished product. To participate and contribute in achieving operation efficiency and performance execution. To execute all documentation work keeping in view of Compliance and Documentation integrity.

Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products. Support with preparation, review and compilation of documents within the framework of regulatory affairs projects. Communicate with clients and Health Authorities in close cooperation with the respective lead. Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective l...

Job Title: R&D Manager Department: Research & Development, Quality Control Location: Dhamdod Factory Reporting To: Director, Research & Development Employment Type: Full-Time Job Summary: The R&D Manager will oversee research and development activities to innovate and improve fertilizer formulations and production processes. The role also includes managing the quality control function to ensure all products meet regulatory standards and customer specifications. The candidate should possess strong scientific knowledge, regulatory awareness, and leadership skills to drive technical excellence. Key Responsibilities: Develop new formulations for fertilizers, biofertilizers, and micronutrient ble...

Please share your resume at anita.searchrx@gmail.com Role & responsibilities Preparation, compilation, and review of Drug Master Files (DMFs) and Active Substance Master Files (ASMFs) for submission to various regulatory authorities (USFDA, EDQM, TGA, PMDA, etc.). Handle query responses from global regulatory agencies and ensure timely and accurate replies. Coordinate with R&D, Quality Assurance, Quality Control, and Production teams for regulatory data collation. Review of technical documents such as specifications, analytical methods, process descriptions, and stability data. Support in the preparation of Annual Product Reviews and Post-Approval Changes . Maintain and update regulatory dat...

The Regulatory Controls Associate will be an integral member of the CB & IB Business Financial Crime Business Controls Oversight team, based in Mumbai or Bangalore. In this role, the Associate will support the business in meeting various Financial crime controls and Regulatory requirements. Key responsibilities include performing essential control activities, assessing and interpreting policy requirements, and conducting gap analysis through process mapping. The associate will also contribute to the design, implementation, and ongoing reporting of business controls, ensuring robust compliance and effective regulatory oversight within the organization. Your key responsibilities Perform gap an...

We are seeking a highly skilled and experienced Senior Product Specialist to join our team The ideal candidate will possess strong analytical skills, good business acumen, and excellent presentation skills They will have a deep understanding of the product management lifecycle and experience with payments and payment reporting, particularly with card payments, focusing on disputes and declines Responsibilities:- Create decks with narratives related to new enhancements and functionalities in order to socialize with internal and external stakeholders Collaborate with the Product Development team and roadmap owners to understand how new functionalities work, what the added value is, and contrib...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

GM – Regulatory Operations (India) will lead Company's India regulatory team, supporting global pharma, biotech & medical device clients with RA & compliance. Requires 8–10 yrs regulatory ops & 5–6 yrs leadership in pharma/RA CRO for US/EU clients. Required Candidate profile PhD/MD/PharmD in Life Sciences with 15+ yrs in RA/clinical/pharma; 5+ yrs leadership; global submission expertise (US/EU/India); strong ICH/GxP knowledge; CRO ops & client management experience.

Regulatory Compliance & Monitoring Policy Formulation & Advisory Experience working with secretariats and government bodies to facilitate policy discussions, representations and submissions. Market Research and Policy-Driven GTM Alignment Health insurance Annual bonus

This job is with Johnson & Johnson, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal.?Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.?Learn more at ht...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with AML and Fraud mgmt experience.Understand & implement laws, and regulations designed to stop the practice of generating income through illegal actions during transfer of funds. Anti Money Laundering law covers limited number of transactions and criminal behaviors to prevent terrorist financin...

To work as per cGMP and ensure its compliance. Responsible to take training before execution of allotted work. Responsible to follow safety precaution as per laboratory procedure. Responsible for execution of characterization activity for drug substance and drug product using analytical technique such as NMR / Raman Responsible for identification of extraneous peaks by LCMS and GCMS. Responsible for method development of Nitrosamine impurities & Genotoxic impurities by GCMS / LCMS. Regulatory guideline knowledge for US & other advanced markets will be desired.