2122 Regulatory Affairs Jobs - Page 27

Jubilant Pharma Limited offers a diverse range of products and services to customers globally through its two key segments - Specialty Pharmaceuticals and Generics & APIs. As a wholly-owned subsidiary of Jubilant Pharma, Jubilant Generics (JGL) plays a crucial role in the organization's operations. JGL has Research & Development units in Noida and Mysore, along with manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand. The Mysore facility, spread over 69 acres, is a USFDA approved site specializing in the manufacturing of APIs that cater to global sales. The API portfolio primarily focuses on Lifestyle driven Therapeutic Areas such as CVS and CNS, emphasizing complex and n...

You are a proactive and detail-oriented Assistant Manager in Regulatory Affairs (EU & UK) with a Masters Degree in Pharmacy (M.Pharm or equivalent) having 4 to 6 years of experience. You will be responsible for driving CMC documentation, regulatory submissions, and lifecycle management for the EU & UK markets, ensuring compliance with regional and international guidelines. Your key responsibilities will include conducting comprehensive CMC reviews of technical documentation for regulatory filings across the EU and UK markets, performing Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards, developing and implementing ...

As a Manager/Senior Manager in the Global Regulatory Affairs department based in Gurgaon, you will play a crucial role in providing Regulatory CMC Product Leadership for branded products being developed for advanced markets such as the US, EU, and Canada. Your responsibilities will include ensuring timely submission of annual reports and supplements for product continuity, assessing regulatory milestones, and developing CMC Regulatory Strategy Documents for projects of increasing complexity. You will lead regulatory activities in product in-license/due diligence review, product divestment, and product withdrawal. Your role will involve managing the execution of CMC documentation, supporting ...

The Regulatory Affairs - International Business role at Nexaa VRA Lifescience Pvt Ltd is a full-time position based in Dehradun. As a Regulatory Affairs professional, you will play a crucial role in ensuring compliance with international regulatory agencies. Your responsibilities will include preparing and submitting regulatory documents, staying updated on regulations and guidelines, liaising with international business partners, and providing guidance on regulatory requirements and strategies. You will be actively involved in managing regulatory submissions, reviewing product labels and marketing materials, and collaborating with various teams to ensure adherence to regulatory standards. T...

As an ideal candidate for this position, you should possess approximately 10 years of general experience and at least 7 years of relevant experience in regulatory affairs and research & development. Your background should include a strong knowledge of vaccine regulations, as well as hands-on experience in vaccine projects. Your primary responsibilities will include supporting human resource mapping and capacity building activities for National Regulatory Authorities (NRAs) in the country, tailored to their status as Vaccine Producing or Importing entities. You will be involved in NRA assessment and benchmarking, particularly for CDSCO in India and BFDA in Bhutan. Additionally, you will provi...

As a Sr. Executive / Assistant Manager in Radiology Quality, you will be responsible for playing a critical role in designing and delivering NABH accreditation for VDC Radiology practice. Your main duties will include visiting VDC centres to observe Radiology practices, designing quality parameters, and preparing SOPs. You will need to have relevant educational qualifications in M.H.M/ Quality Management/ Radiology Services with national and international certifications. Additionally, you should possess document management skills and have prior experience in Quality Management, especially in NABH accreditation in a reputable hospital. Proficiency in English, Telugu, and Hindi is a requiremen...

Summary The Senior Regulatory Coordinator (Sr. RC) works under close supervision to support for development including line extension and /maintenance projects through development, registration, and approval including post approval commitments. To maximize operational effectiveness, Collaborate with RA GDD Development Units, RA GDD CMC, Regional Representatives (MoW, LACan, EU, China, Japan), Novartis Technical Operations (NTO), and Quality Assurance to align on planning, execution, communication, and completion of assigned projects. About The Role Key Responsibilities Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COAs and othe...

As the Environmental Compliance Manager, you will be responsible for leading and managing the end-to-end execution of environmental clearance processes for new projects. Your role will involve ensuring compliance with environmental laws, regulations, and permits, as well as developing and implementing environmental management systems. You will conduct environmental impact assessments and risk evaluations, providing guidance on environmental best practices and sustainability initiatives. Collaboration with cross-functional teams to integrate environmental considerations into business operations will be a key aspect of your responsibilities. Monitoring and reporting on environmental performanc...

You will be responsible for understanding the current practices, medicines, and trends in the specific therapeutic area by engaging in doctor visits, attending scientific symposia, and reviewing key therapeutic journals. This information will be crucial for providing relevant insights to both internal and external stakeholders. Your role will also involve publishing scientific articles related to company products and creating presentations for doctors, including those for Continuing Medical Education (CME) and product launches. As part of the team, you will contribute to the implementation of the medico marketing strategy and engage in field visits to doctors for product management purposes,...

As the Director of Corporate Quality Assurance, your primary responsibility is to ensure the overall cost of various Capex & Revenue projects is maintained within the budgeted numbers. You will monitor and track the Cost of quality to keep it under control and establish the Cost of Poor Quality process for existing and new businesses. Additionally, you will contribute to Improvement Projects for cost reduction in cross-functional teams. In terms of customer service, you will lead efforts to handle customer complaints and product quality issues promptly. You will guide the Customer Relationship Management team to incorporate customer feedback into quality improvements, monitor product perform...

As an Assistant Officer - Quality Assurance at Capital Foods located in Nahuli, you will play a crucial role in the Quality Assurance & Regulatory Affairs function reporting to the Assistant Manager - Quality Assurance. Your key deliverables in this role will include: Financial Outcomes: - Tracking the Cost of poor quality, reporting, and executing initiatives to reduce it. - Participating in the RCA process, executing corrective actions, and monitoring their effectiveness. - Daily reporting of Quality Key Performance Indicators (KPIs). Customer Service: - Coordinating with customer departments such as Quality Assurance and functional departments like Warehouse, Engineering, Production, EHS,...

Job Description As a Regulatory Specialist at Medhaj Techno Concept Pvt. Ltd., your primary responsibility will be to ensure compliance with regulatory requirements and analyze regulatory affairs effectively. You will play a crucial role in communicating with stakeholders and providing regulatory guidance to the team. Your day-to-day tasks will involve monitoring regulatory changes, submitting reports, and ensuring adherence to all regulatory standards. To excel in this role, you are required to have an MBA in Power Management or Finance along with a B.E./B.Tech degree. Additionally, a minimum of 6 years of experience post MBA is necessary. Your expertise should include a strong understandin...

Job Description Summary Provides quality and regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for Field Actions. Works closely with the Business Segments, Regulatory RA, and Services to provide guidance from initiation to closure of Field Actions. Has knowledge of best practices, in-depth understanding of key business drivers and uses this to accomplish their work. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and ...

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 decision, conferring w...

As a Manager, Medical Writing & Research Affairs at TECCRO, you will play a crucial role in preparing high-quality scientific documents, including clinical study reports, research papers, regulatory submissions, and publications for medical journals. Your responsibilities will involve collaborating closely with clinical and research teams to ensure that manuscripts meet publication standards for major medical journals and align with the latest scientific research and TECCRO's clinical objectives. Your role will also require you to conduct thorough literature reviews, contribute to the design of clinical trials, and stay updated with current scientific and clinical advancements in the fields ...

You should have 8-12 years of experience in Pharmacovigilance, with familiarity in Pharmacovigilance Risk Management Plan (RMP) processes and Pharmacovigilance Periodic Safety Reports (PSR) processes. You should also have experience in translating business requirements into technical specifications and have worked with Top-30 Pharma companies. Cross-functional experience in safety, pharmacovigilance, and regulatory affairs is desired. Experience with Veeva.RIM and Feith Orbit platform is a plus. Strong organizational and verbal/written communication skills are essential for this role. If you meet the above criteria, please share your updated resume with us at connect@datakaar.com.,

The US Healthcare Recruiter position at Allime Tech Solutions Pvt. Ltd. in Hyderabad requires a minimum of 4 years of experience in recruitment. As a US Healthcare Recruiter, your primary responsibility will be to source, screen, and recruit qualified candidates for various healthcare roles. These roles include Medical Billing Specialists, Accounts Receivable (AR) Follow-up Specialists, Coding and Compliance Officers, Healthcare Business Analysts, Project Managers, and more. You will collaborate with hiring managers and department heads to understand recruitment needs thoroughly. Please refrain from applying if your profile does not align with the job description or the required qualificatio...

As a Senior Chemist in the Pharma Manufacturing Industry located in Vatva, Ahmedabad, your primary responsibility will be to utilize your M.Sc. in Organic Chemistry along with 5 to 8 years of experience in API/Intermediates manufacturing to contribute significantly to the organization. Your role will involve hands-on experience in synthesizing APIs and intermediates, conducting literature searches using platforms such as SciFinder, Chemical Abstracts, Free Patent Online, and Journals. You will be responsible for feasibility studies, route selection for synthesis, multi-step synthesis, yield improvement, and cost reduction strategies. Additionally, you will be involved in extraction, purifica...

Immediate opening for Chemical and Pharma Industries Qualification - BE / B Tech / BSc / MSc - Chemistry / Chemical / Biotechnology / Biochemistry / Microbiology / Petrochemical Designation - Production chemist / Qc - QA / Regulatory Affairs / WTP / STP / ETP / Purchase location - chennai / coimbatore / Hosure Experience - Freshers ( pharma related Experience only apply ) Immediate Joining can contact Keerthana HR - 9384810696 ( call or watsapp ) Drop your resume to this mail id - hr02jjjobs@gmail.com Venue Details: JJ Jobs S2, 1/44,2nd floor , parvathi Apartment / Bazar road jj nagar , Mogappair East Chennai -37 Land mark- MMM hospital & Green park cafeteria website -jjjobs.co.in

1. Product registrations /Submissions -Leads and coordinates project registrations for complex filings, including new product introductions -Identifies and collects data needed, or delegates where appropriate -Seeks and evaluates expert advice and technical support where necessary -Prepares responses to deficiency letters 2. Relationships Cross Functional team work -Represents Regulatory Affairs at relevant meetings and presents agreed RA position -Provides expert advice and technical support to cross-functional colleagues -Monitors actual versus planned activities and timelines. -Proactively identifies, communicates and mitigates risks and issues impacting project progression. 3. Affiliate ...

MAIN PURPOSE OF ROLE Experienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in the area of Regulatory Affairs. Requires capacity to apply skills/knowledge within the context of specific needs or requirements. MAIN RESPONSIBILITIES As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liaison throughout product lifecycle. Participates in some of the...

Primary Job Function: Independently: 1. Product registrations /Submissions Leads and coordinates project registrations for complex filings, including new product introductions Identifies and collects data needed, or delegates where appropriate Seeks and evaluates expert advice and technical support where necessary Prepares responses to deficiency letters 2. Relationships Cross Functional team work Represents Regulatory Affairs at relevant meetings and presents agreed RA position Provides expert advice and technical support to cross-functional colleagues Monitors actual versus planned activities and timelines. Proactively identifies, communicates and mitigates risks and issues impacting proje...

MAIN PURPOSE OF ROLE : Leads/supervises a team of more than 2 professionals within the Regulatory Affairs Sub-Function. First level manager of a work team that may comprise professionals, technical and/or administrative staff. Typically without budget or hire/fire authority. Focuses on mentoring, coaching, and coordination. MAIN RESPONSIBILITIES : As the Team Leader (Professionals) of the Regulatory Affairs Sub-Function, supervises professionals in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liaison throug...

Jubilant Pharma Limited is a global integrated pharmaceutical company that offers a diverse range of products and services to customers worldwide. The business is organized into two segments: Specialty Pharmaceuticals, which includes 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, with Research & Development units in Noida and Mysore, India. JGL operates two manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand, specializ...

About Syngene: Syngene is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything you do personally and professionally. Safety is placed at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs in letter and spirit. It is mandatory for all roles at Syngene to adhere to safe practices and procedures, contributing to the development of procedures, practices, and systems that ensure safe operations and compliance to the company's integrity and quality standar...