2122 Regulatory Affairs Jobs - Page 28

The primary responsibility of this role is to manage Regulatory Affairs in compliance with relevant regulations and guidelines for the organization. As a Regulatory Affairs Manager at DDReg, you will be involved in reviewing clinical, biopharmaceutical, non-clinical, and labelling documentation. Your duties will include preparing and reviewing non-CMC sections, Variations, site transfers, and conducting post-approval gap analysis. Additionally, you will support the regulatory function through document management, electronic submission compilation, and other group management activities as needed. Collaboration with various departments such as Regulatory Affairs, Quality Assurance, Quality Con...

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization collaborating with global health and science authorities to establish quality standards for medicines, dietary supplements, and food ingredients. USP's core value of Passion for Quality is upheld by over 1,300 dedicated professionals across twenty global locations, working towards ensuring the supply of safe, quality medicines and supplements worldwide. Emphasizing inclusivity, USP values mentorship, professional growth, and a culture promoting Diversity, Equity, Inclusion, and Belonging for a world of quality healthcare assurance. As a Supervisor at USP, your primary responsibility is to lead the acquisition a...

What you will do 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 decis...

Lead Analyst- Emerging Markets Strategy: Elevate Your Impact Through Innovation and Learning Evalueserve is a global leader in delivering innovative and sustainable solutions to a diverse range of clients, including over 30% of Fortune 500 companies. With a presence in more than 45 countries across five continents, we excel in leveraging state-of-the-art technology, artificial intelligence, and unparalleled subject matter expertise to elevate our clients' business impact and strategic decision-making. Our team of over 4, 500 talented professionals operates in countries such as India, China, Chile, Romania, the US, and Canada. Our global network also extends to emerging markets like Colombia,...

Description Regulatory Manager (CMC, EU & Japan/China) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem ...

Message to applicants applying to work in the U.S. and/or Canada: When available, the salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. and/or Canada locations, not including equity or benefits. For non-sales roles the hiring ranges reflect base salary only; employees are also eligible to receive annual bonuses. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidates hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full sala...

Role & responsibilities 1) Compilation , review of dossier for US , EU , AU, Canada & IL market (ORALS/NON ORALS) 2) Review of query response prepared and compiled by regulatory associates 3) Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management

Role & responsibilities Candidates having experience working for Russia, CIS, APAC, SSA (Sun Saharan African) and Brazil /LATAM market

Looking for a fresher in Regulatory Affairs to assist in document preparation, product registration, and compliance with national and international regulations. Strong communication skills, attention to detail, and a science background are preferred.

Purpose of the Job: To ensure Clariant's products comply with relevant chemical regulations, material requirements, and trade regulations across assigned regions. Verify proper HS (Harmonized System or Tariff classification) code for import/export compliance. Responsibility: • Drive strategic initiatives within chemical regulatory framework. • Investigate and analyze chemical structures to ensure regulatory compliance • Determine appropriate HS codes for chemical products based on structural analysis• Follow Regulation: CWC (Chemical Weapons Convention), INCB (International Narcotics Control Board), Central Insecticide Board or SCOMET(Special Chemicals, Organisms, Materials, Equipment and Te...

Role & responsibilities Review and authorize change controls, assessing their impact on regulatory submissions. * Coordinate and organize meetings with cross-functional teams to discuss IRs, DRLs, and CR letters from agencies; circulate Minutes of Meeting (MoM) and follow up on action items. * Compile and coordinate high-quality CMC regulatory submissions for the US market in compliance with current regulatory guidelines and timelines. * Assess change controls from formulation plants and categorize them based on risk to product quality and compliance. * Plan, review, and submit CBE, CBE-30, and Prior Approval Supplements (PAS). * Draft high-quality responses to regulatory agency letters (IR,...

Skillventory is mandated to hire AVP, Regulatory Compliance with a leading Health Insurance company for Gurgaon. Were looking for an AVP Regulatory Compliance to drive a culture of compliance, ensure regulatory adherence, and support governance across business functions. Location: Gurgaon Experience: Minimum 8+ years in regulatory compliance, preferably in insurance and Team Handling Must Qualification: Graduate/Postgraduate with relevant certifications (Law/CS/MBA preferred) Key Responsibilities: Ensure implementation of new laws & regulations across functions Review insurance products, marketing materials, and customer communications for regulatory compliance Audit internal processes (sale...

Role & responsibilities Review of post approval changes and evaluating its impact on the products. Preparation of appropriate post approval submissions such as PAS, CBE 30 & 0, and annual reports. Management of product life cycle. Managing Team Dosage Form : Solid Oral / Nasal / Liquid/ Ophthalmics Preferred candidate profile 10+ Years of USFDA post approval submission experience USFDA Experience Exposure to ANDA /NDA post approval submissions Please share updated CV on hr19@hectorandstreak.com

**Job Description:** As a CSV Lead in the Drug Safety domain, you will be responsible for overseeing the validation process of safety systems, including but not limited, or other drug safety databases. You will lead cross-functional teams and manage CSV lifecycle activities, including planning, executing, and documenting validation efforts for drug safety systems. **Key Responsibilities:** - Lead validation efforts for drug safety systems such other similar platforms, ensuring compliance with industry standards (21 CFR Part 11, GxP, and other relevant regulations). - Develop, review, and approve validation documentation, including Validation Plans, Protocols, Reports, and Traceability Matric...

* B.Pharm/M.Pharm with 4-6 years in Regulatory Affairs, experience in dossier preparation, and country-specific formats. * Prepare dossiers, handle queries, manage re-registration and renewal applications.

Roles and Responsibilities Prepare dossiers for regulatory submissions, including CTD/eCTD format. Ensure compliance with USFDA regulations through dossier compilation and submission. Manage RA activities from pre-clinical to post-marketing stages, covering both domestic and international markets. Develop expertise in drug regulatory affairs, focusing on row market requirements. Collaborate with cross-functional teams to ensure timely completion of projects.

Jubilant Pharma Limited is a global integrated pharmaceutical company that offers a wide range of products and services to customers across different 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. JGL operates two manufacturing facilities in Mysore, Karnataka,...

Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagno...

The AGM / DGM Technical Services position requires a candidate with a B.Pharma / M.Pharma qualification and 15 to 20 years of experience in tech transfer activities of solid oral dosage forms for regulated markets. The ideal candidate should have experience in managing a team of 15 to 20 scientists, documentation officers, and technicians. As an AGM / DGM Technical Services in Kandivali, Mumbai, your responsibilities will include planning and executing scale-up and Exhibit batches of solid oral dosage forms for regulated markets such as US, EU, ROW, and Canada. You will be accountable for ensuring the timely initiation of stability studies for exhibit batches and overseeing the technical ser...

As a Quality Control (QC) Analyst at Jubilant Generics, you will be responsible for various tasks related to ensuring the quality and compliance of pharmaceutical products. Your role will involve sampling and analyzing packing materials and raw materials, conducting in-process quality control, and preparing specifications and test procedures. Additionally, you will be responsible for maintaining artwork and shade cards, as well as calibrating and validating instruments and equipment. Your attention to detail will be crucial in recording analytical data accurately and preparing records of analysis for both raw materials and finished products, including stability samples. In this role, it is e...

The Clinical Research Scientist position at NIRAMAI Health Analytix requires a Strong Leader, Clinical Specialist, and Medical Expert with an entrepreneurial mindset to lead the clinical research and marketing division. Your role will be crucial in furthering NIRAMAI's mission of becoming a world-class AI Healthcare organization known for its Innovation, Compliance, and Compassion. Your primary responsibilities will include developing and implementing strategies for the clinical function at NIRAMAI, coordinating international and national clinical trials, and establishing a global network of Key-Opinion-Leaders to promote the adoption of innovative diagnostic solutions. You will also be task...

As the Director of Regulatory Research & Intelligence at Kamet Consulting Group, you will be responsible for leading and developing a team of research consultants in the life sciences and healthcare technology industry. Your role will involve overseeing regulatory intelligence, compliance support, and advisory services for clients in the pharmaceutical and medical device sectors. You will be the key authority for regulatory research activities in India, ensuring delivery excellence, quality control, and strategic insights. Your core responsibilities will include building and mentoring a team of research consultants, setting performance targets, and fostering their professional development. Y...

As the Manager of India OSD Pre-approval ANDA portfolio, Injectable Drug Substance pre-approval portfolio, and Global DMF Review portfolio, your primary responsibilities involve providing Drug substance/nitrosamine review support to complex projects, including 505(b)(2), Europe & Canada projects. You will also participate in cross-functional meetings to address regulatory/technical issues and facilitate decision-making processes. Additionally, it is essential to engage with API vendors to gather relevant information and prevent any deficiencies in Drug Substance. Your role also encompasses bridging DMF/API related regulatory decisions between Raks & Amneal Teams, conducting training sessions...

Position Overview: A Legal Manager is responsible for overseeing legal compliance, managing contracts, mitigating risks, and providing legal advice to the company. This role ensures that the organization's operations align with applicable laws and regulations while protecting its interests. Key Responsibilities: 1. Legal Compliance & Regulatory Affairs Ensure compliance with local, state, and national laws and regulations. Keep the company updated on changes in laws affecting business operations. Manage labour laws, environmental regulations, and industry-specific legal requirements. Handle licensing, permits, and statutory compliance. 2. Contract Management Draft, review, and negotiate cont...

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 wide varie...