2122 Regulatory Affairs Jobs - Page 17

: Develops and implements submission strategies for 505(b)(2), ANDAs and NDAs. Leads and ensures implementation of the planning, writing and review of all regulatory submissions to support of all global projects for ANDAs and 505(b0(2) NDAs and EU and UK Marketing Authorizations. Critically reviews and approves documentation from clinical development, non-clinical development, Research and Development (R&D), Quality, Technical Operations, Labeling and other appropriate departments, internal and stakeholders, vendors and consultants. Ensures that project timelines are developed and communicated; evaluates changes to maintain submission goals and timelines; communicates any delays along with t...

About The Role Skill required: AML fraud mgmt. Financial Crime & Fraud Management Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? The Risk & Controls Analyst will be a key member of the Client s Operations Team, supporting the day-to-day management of the First Line of Defense risk management framework and related activities.This role involves working collaboratively across the bank to identify, assess, monitor, and mitigate operational risks.Strategize, architect, Analyse, design, implement and contribute to engagements involving tools and processes associated with the prevention (or management ) of fraud What ...

About The Role Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP HCM Payroll Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that project goals are met, facilitating discussions to address challenges, and guiding your team through the development process. You will also be ...

Roles and Responsibilities Conduct analytical research, including method development, validation, and sample analysis to support regulatory submissions. Collaborate with cross-functional teams to ensure compliance with cGMP guidelines during API manufacturing process development.

Key skills required by this role includes: Understand Regulatory operations Gather, review and analyse data regarding the business and its operations; prepare models and process maps for improvements; and communicate findings and suggestions to key stakeholders Understanding software requirements, ability to translate business need into functional and technical requirements Skilled in documentation and timely response and sharing of information Ability to perform discussion with customer Ability to effectively report on status of work Break down requirements in user stories Ability to verify the functionality in the solution. Ability to write test cases/scripts and execute them.

Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory s...

Regulatory affairs professional with experience in managing product listings for different markets and ensuring full compliance with all regulations. Proven track record of collaborating with renowned global cosmetic brands to navigate and meet regulatory requirements across multiple regions, including the USA, Canada, Australia, New Zealand and Middle East. Proficient in cosmetic regulations, including several regulations and versed with interpreting and applying recent regulatory updates. Highly skilled in managing compliance with state-specific regulations. Adept at leading cross-functional teams to support regulatory submissions and ensure product compliance, driving efficiency and marke...

Position Summary: Freyr is seeking an experienced individual to join their Medical Device Team. This position involves working directly with clients with software enabled medical devices or software as a medical device to serve as an advisor on regulatory strategy including the development of regulatory strategy documents, documentation to support premarket submissions, and preparation and submission of premarket applications as well as participation in FDA meetings and other regulatory interactions. The role is 50% billable with the remaining time being devoted to business development/marketing as well as mentorship and training of the more junior staff. The ideal candidate will possess in-...

You will be responsible for the development of new products and optimization of existing formulas across different product lines such as solid dosage products (tablets, capsules) and other delivery forms (liquids, powders) for regulated markets including the US, Europe, and ROW. Your tasks will involve formulation and process development of oral dosage forms, troubleshooting unresolved formula issues, designing formulation trials, and evaluating stability data to finalize composition. Additionally, you will develop manufacturing processes for R&D formulations to ensure successful technical transfer for large-scale batches. In this role, you will write and review various documents such as mas...

Jubilant Pharma Limited is a global integrated pharmaceutical company that offers a diverse range of products and services to customers worldwide. The company is organized into two main segments: Specialty Pharmaceuticals and Generics & APIs. Under Specialty Pharmaceuticals, Jubilant Pharma focuses on Radiopharmaceuticals, Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products. The Generics & APIs segment includes Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) operates as a wholly-owned subsidiary of Jubilant Pharma and has Research & Development units in Noida and Mysore, India. The manufacturing facilities at Mysore and ...

As the Lead Medical Writer at Tatvacare, you will be responsible for developing and reviewing high-quality medical content, including scientific publications such as original research articles, consensus reports, review articles, and clinical trial documentation. Your role will involve collaborating with cross-functional teams, providing scientific expertise, and ensuring compliance with regulatory and industry standards. The ideal candidate for this position will have extensive experience in medical writing, particularly in clinical development, regulatory affairs, and digital health research. Your key responsibilities will include developing and finalizing medical writing documents, coordi...

The role of Global Strategy Leader is a remote position responsible for overseeing and implementing regulatory strategies for the global pharmaceutical portfolio of the company. Your primary focus will be on shaping regulatory decisions, managing complex global submissions, and ensuring successful product development, approval, and market access for the company's pharmaceutical products. In this role, you will collaborate closely with internal and external stakeholders to align regulatory strategies with business objectives and drive the timely delivery of high-quality pharmaceutical products. Your key responsibilities will include leading the development of global regulatory strategies, col...

You should have a Masters or Bachelors degree in Science / Pharmacy along with at least 7-10 years of experience in a similar function within the pharmaceutical industry. As a Regulatory Affairs professional, you must have supported regulatory affairs functions on finished dosage forms. It is essential to possess a sound and deep knowledge of current Regulatory / GMP requirements including US FDA, EU GMP, and PIC/s. Your role will require strong initiative skills, enabling you to work both independently and as part of a team. Proficiency in English communication is vital for effective coordination within the organization and with external stakeholders. Additionally, you should have advanced ...

The Senior Regulatory Administrator (SRA) role is crucial in providing vital administration and operational support to the Regulatory Affairs department. As an SRA, your primary responsibility is to ensure the efficient management and upkeep of regulatory documents within the regulatory systems. Your pivotal role involves overseeing the accuracy, compliance, and timely submission of regulatory documentation to regulatory bodies such as the FDA, EMA, and other international authorities. Your duties will include managing the organization of regulatory documents for submissions, ensuring adherence to relevant guidelines and regulations, optimizing processes, mentoring team members, and fosterin...

As a Regulatory Affairs Associate II, Labeling at Teva Pharmaceuticals, you will play a crucial role in preparing and revising high-quality US Gx labeling documents for submission under an ANDA and/or 505(b)(2). Your responsibilities will include ensuring compliance with federal regulations, guidance documents, and internal procedures while meeting deadlines aligned with company objectives. You will be expected to work with minimal supervision and demonstrate a thorough understanding of US FDA labeling regulations and guidance documents. Your tasks will involve creating compliant Structured Product Labeling (SPL) files, ensuring complete drug listing information, and adhering to compliance r...

PopVax, an Indian biotechnology company based in Hyderabad, with a primarily remote US subsidiary nominally located in New York, is seeking a senior regulatory executive. The company is funded through research agreements with the Gates Foundation and Vitalik Buterin's biosecurity company, Balvi. Over the past year, PopVax has been developing a novel second-generation mRNA platform for low-cost broadly-protective vaccines using computationally-driven antigen design. The primary focus is on an open-source booster vaccine candidate designed to provide protection against the entire sarbecovirus species and potentially the betacoronavirus genus, including current and future strains of SARS-CoV-2,...

As a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations), your main responsibility will be to develop and execute global regulatory strategies for combination product devices. You will play a crucial role in ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. To excel in this role, you should have a minimum of 5 years of regulatory affairs experience in biosimilars, biologics, or combination product development. Your expertise will be instrumental in providing regulatory guidance on device design, human factors, risk management, and manufa...

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...

-Plan, prepare and review of high-quality eCTD dossier within stipulated timelines for submission in regulated markets like EU/Australia/Canada/UK/ South Africa. -Preparing query responses for submission to regulatory agencies and clients, within the stipulated timelines. - Preliminary review of the In-licence dossier and preparation of the due diligence report. -Co-ordination with cross-functional teams at manufacturing plant and RnD for retrieving documents and any matters related to the submission. -Technical review of GMP documents and RnD documents for submission purpose. -Hands on experience with eCTD software and be able to compile eCTD sequence for EU/Australia/Canada/UK/ South Afric...

Role Purpose 1) Support all documentation and regulatory requirements for international markets 2) Application management with FDA for license 3) Co-ordinate for Export Orders 4) Technical support for Plant / IPQC Key Responsibilities 1) Product Registration and Company Registration in International Market 2) Applications for domestic & Export licenses to FDA 3) Co-ordination for Export orders 4) Support plant with technical information when needed Key Activities 1) Documentation for application filing for licenses to FDA 2) Work with FDA/CDSCO as required during the filing of paper work for licenses, etc. 3) Art work approvals 4) Finalizing export orders with regards to packing, packaging m...

Compilation and submission of eCTD dossier for new product (Finished) application & post approval submission Query response, PAS,CBE and annual report, drug listing Review of artwork and submission of labelling section Maintain product life cycle.

SUMMARY Job Title: Healthcare Administration Services Representative Location : Airoli, On-site Shift Timing : 5:30 PM - 3:00 AM We are in search of individuals with exceptional communication abilities and the flexibility to work different shifts to become part of our team as Healthcare Administration Services Representatives. As a part of this role, you will have a significant impact on integrating digital advancements into healthcare operations to ensure the provision of efficient and effective services. Responsibilities : Collaborate closely with the Healthcare Management team to supervise the administration of various healthcare facilities Oversee day-to-day operations, department activi...

As a Formulations Scientist located in Hyderabad, India, you will be responsible for developing oral solid dosage forms of both Non-DEA and DEA substances. Your key functions will include conducting Literature Search, Pre-Formulation, and Formulation Design to ensure the development of stable, Bioequivalent, and Manufacturable generic solid oral formulations. Your responsibilities will involve being a mentor and motivator to your team. You will be tasked with developing robust formulations and processes for immediate release and modified release tablet and capsule dosage forms. Additionally, you will evaluate patents, develop non-infringement strategies, and have the capability of developing...

As a Principal Cybersecurity Engineer at Boston Scientific, you will play a crucial role in designing, developing, and testing cybersecurity features and controls in the regulated medical device industry. Your expertise will guide the cybersecurity strategy throughout the product lifecycle within the R&D Division, ensuring compliance with relevant standards and regulations. Your responsibilities will include leading the design, implementation, and maintenance of comprehensive security measures across all stages of medical device development. You will focus on protecting patient data and device integrity by creating secure architectures for new medical devices, conducting vulnerability assess...

As a member of the Quality Control department at Jubilant Pharma Limited, your primary responsibilities will include sampling and analyzing packing materials and raw materials, conducting in-process quality control checks, and ensuring compliance with cGMP and GLP standards. Your role will involve the preparation of specifications, general test procedures, and standard test procedures. Additionally, you will be responsible for maintaining artwork and shade cards, as well as calibrating and validating instruments and equipment used in the manufacturing process. A crucial aspect of your job will be the accurate recording of analytical data and the preparation of records of analysis for both ra...