3208 Regulatory Affairs Jobs - Page 14

Company Description Hayai Pharma is the Exporter of finished formulation of medicines accross various geographies. Role Description This is a full-time on-site role for a Senior Manager Regulatory Affairs, based in Meerut, Delhi NCR. The Senior Manager Regulatory Affairs will be responsible for preparations of filings for product or site registration in the target market. This would include compilation of dossiers, coordination with stakeholders and other allied activities. Prior experience of 5 years in the same field is a must Qualifications Experience in Regulatory Affairs and Regulatory Submissions Knowledge of Quality Systems Strong analytical and problem-solving skills Excellent writte...

Job Title: Manager (RA) Location: Faridabad Department: Regulatory Affairs (RA) Job Overview: We are seeking a meticulous Documentation Officer / Manager to manage regulatory documentation and ensure compliance with ISO 13485, EU MDR, FDA, and other regulatory standards. Key Responsibilities: Prepare, maintain, and review regulatory documentation as per ISO 13485, EU MDR, and FDA requirements. Support regulatory audits , inspections, and compliance activities. Ensure all documentation is accurate, complete, and up-to-date . Liaise with cross-functional teams (QA, Production, R&D) to gather necessary information for submissions. Maintain document control systems and track regulatory submissio...

E We are looking for a passionate and detail-oriented Regulatory Affairs Specialist (Fresher) to join our life sciences and healthcare compliance team. The ideal candidate will be responsible for assisting in the preparation, review, and submission of regulatory documents and ensuring adherence to national and international standards for product approval and compliance. This role offers a great opportunity for recent graduates in Pharmacy, Biotechnology, Life Sciences, or related fields to begin their career in the pharmaceutical and healthcare regulatory sector . Key Responsibilities: Assist in preparing and submitting regulatory documents to health authorities. Maintain up-to-date knowledg...

We are seeking life science graduates interested in building a long-term career in the Clinical Research domain. This opportunity is part of our industry-integrated Clinical Research Training Program designed to prepare candidates for roles such as CRA, CRC, and Drug Safety Associate . Role Responsibilities (Post-Training Readiness) Understand and support clinical trial processes, site coordination, and documentation Learn Good Clinical Practices (GCP), ICH guidelines, and regulatory frameworks Monitor data collection and compliance Collaborate with CROs, hospitals, and research organizations (Post-placement) Eligibility Criteria Education: B.Sc, B.Pharm, M.Sc, BDS, BPT, BHMS, BAMS, Nursing,...

Help us bring cutting-edge medical treatments to life! Become a key player in clinical research and accelerate advancements in healthcare. Opportunities We offer two paths into the exciting world of clinical research: Internship: Get a hands-on introduction to clinical trials through a time-bound internship program. Ideal for students or recent graduates eager to experience the field. Fresher-Level Position: Launch your career as a Clinical Research Coordinator! This position offers ongoing employment for those committed to this exciting field. Regardless of path, you'll get to: Manage the flow of clinical trials: Oversee study logistics, participant documentation, and ensure the study progr...

As a Safety Aggregate Reporting Manager, you will act as a stand-alone global functional lead, utilizing your 7+ years of experience in Safety Aggregate Report and Analytics (SARA) Center deliverables. Your responsibilities will include: - Leading, authoring, and finalizing aggregate reports such as PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings, and responding to regulatory agency inquiries. - Conducting ongoing literature safety surveillance for marketed and investigational products, identifying ICSRs, evaluating events, and contributing to literature deliverables for aggregate reports and signal management activities. - Serving as a Signal Management Lead on large post-marke...

Role Overview: You will be leading the Quality and Regulatory department of the API and Intermediate business at LOXIM. Your primary focus will be on ensuring quality, compliance, and global regulatory excellence, with a hands-on approach. You are expected to align with cGMP, ICH, and international regulatory standards, strengthen systems, people, and culture. Your deep understanding of API and intermediate processes, global filing requirements, and ability to guide teams through audits, inspections, and technology transfers will be crucial. Key Responsibilities: - Lead QA, QC, Regulatory Affairs, and Compliance functions at all manufacturing sites. - Ensure alignment with cGMP, ICH Q7, and ...

Overview This role will assist the AMESA Supplier Quality Assurance team by conducting re-approvals annually for low risk designated suppliers located in AMESA that supply ingredients to Pepsico. This role will contact suppliers, request, and review returned pre-requisite data and documents, and re-approve the supplier site (3-year reapproval cycle). The role will update the required database(s) to support the re-approval. The expectation is 200 supplier sites per year. The role will also support ancillary programs in AMESA SQA such as gathering program evidence from suppliers and brokers related to Food Fraud, Quality and Food safety Certifications and Contaminants programs as well as updat...

As the Senior Manager of Patient Safety at ADVANZ PHARMA, your primary responsibility will be to monitor and manage all aspects of updating Reference Safety Documents for all ADVANZ PHARMA products globally. You will need to maintain these documents in accordance with applicable guidelines, ensuring a global process along with region-specific processes for writing and managing reference safety documents like CCDS and SmPC. Your experience in writing reference safety documents for various types of drugs will be crucial for this role. **Key Responsibilities:** - Act as a subject matter expert in global labeling requirements, driving continuous improvement initiatives, and upholding high-qualit...

As a Deputy Manager Regulatory Affairs at PolyPeptide Group, you will play a crucial role in bridging operational execution with strategic oversight, ensuring compliance with global regulatory requirements and contributing to the success of the company. **Key Responsibilities:** - **Drug Master File (DMF) Management** - Prepare, review, and submit DMFs in compliance with US (FDA), EU (ASMF and CEP), Canada, China, Korea, Brazil, and other emerging market regulations. - Maintain and update DMFs throughout their lifecycle, including change filings and regulatory correspondence. - **Regulatory Strategy & Compliance** - Develop and implement regulatory strategies for generic synthetic, semi-synt...

Description Medical Writer I (CTT) 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 solvers, innovating ...

CTM Remote ICON plc is a world-leading healthcare intelligence and clinical research organization Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development, We are currently seeking a Clinical Trial Manager to join our diverse and dynamic team at ICON Plc In this critical role, you will be responsible for overseeing the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines As a leader in our research department, you will collaborate with cross-functional teams, manage site relationships, and provide st...

Ability to work with clients to identify business challenges and contribute to client deliverables by refining, analyzing, and structuring relevant data Awareness of latest technologies and trends Logical thinking and problem-solving skills along with an ability to collaborate Primary Skill: Oracle CC&B (OUAF) CIS

As a Formulation Development Scientist at Vantage Nutrition LLP, your role involves formulating and designing new Nutritional/Dietary products or modifying existing ones to meet consumer needs and align with business priorities. Your key responsibilities include: - Formulating and designing new Nutritional/Dietary products such as Pellets for Nutraceutical products, FBD, FBC, Liquid fill in hard capsule, Tablets, Capsules, Soft Gels, Powders, etc. - Conducting early research, literature search, and analyzing feasibility, design, and performance of product ideas or concepts. - Coordinating, documenting, and interpreting data from experiments to understand product robustness. - Partnering with...

Ability to work with clients to identify business challenges and contribute to client deliverables by refining, analyzing, and structuring relevant data Awareness of latest technologies and trends Logical thinking and problem-solving skills along with an ability to collaborate Ability to assess the current processes, identify improvement areas and suggest the technology solutions One or two industry domain knowledge Primary Skill: Oracle CC&B (OUAF) CIS

Candidate should be B.Pharm Candidate should have regulatory exposure/ in previous organisation Candidate should have well command on IPQA activities Candidate should have Command on packaging operations Candidate should be able to work in shift well aware with regulatory requirement

Handling of Manufacturing Compliance i.e. IPQA Activity Handling of QMS Documents like CAPA, and OOS and Change control Handling of APQR Handling of Batch release activity Good in communication skills Exposure of Regulatory audit

Job Title: Manager - Regulatory Affairs / Quality Assurance Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 10-15 years in Quality Assurance and Regulatory Affairs, specifically within the Vaccine, Injectable, and Sterile Industry Educational Qualification: Bachelors or Masters in Pharmacy M.Sc in Biotechnology, Microbiology, or a related field Additional qualifications in life sciences or pharmaceutical sciences are a plus Job Overview: As the Manager QA / Regulatory Affairs , you will play a pivotal role in ensuring that our vaccine , injectable , and sterile pharmaceutical products meet global regulatory requirements and quality assurance (...

Review and preparation of dossiers (ACTD, CTD, eCTD) as per specific country requirements Preparation and verification of regulatory documents. Candidate Profile:- B.Pharm / M.Pharm / MSc in related discipline. 1-3 years of experience.

Role & responsibilities Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. Regulatory Compliance and Updates: Stay informed of changes in Asian or Regulated market regulations, ensuring timely implementation of updates to maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. Documentation and Record Keeping: Maintain well-organized records of submissions, ...

1. Regulatory Submissions & Approvals: Prepare, review, and submit drug regulatory dossiers (e.g., Formulations, APIs, supplements) to CDSCO, state FDA, and other authorities . Follow up on approval status, queries, and responses with regulatory bodies. Maintain trackers of pending applications, renewal dates, and approvals . 2. Documentation & Compliance: Ensure preparation of regulatory documents, SOPs, product labeling, packaging inserts, and promotional materials in compliance with regulatory norms. Maintain accurate records of regulatory correspondence, approvals, and submissions . Support internal audits and inspections with regulatory documentation. 3. Product Lifecycle Management: Mo...

Position Summary: The Executive Regulatory Affairs (Biosimilars) will be responsible for the preparation, review, and submission of high-quality CMC documentation to support regulatory filings in the US, Europe, and other global markets. The role involves cross-functional collaboration, drafting of eCTD modules, and ensuring compliance with international regulatory requirements for biosimilar products. Role & responsibilities Review and finalize CMC (Chemistry, Manufacturing, and Controls) documents for US (FDA) and European (EMA) regulatory submissions. Draft, compile, and review eCTD sections , ensuring compliance with current regulatory and technical standards. Author and review key regul...

Regulatory Compliance Product Registration & Approvals Safety & Risk Management Audit Support Cross-functional Collaboration Import/Export Control

Role & responsibilities 1. Regulation movement Grasping - Participate in regulation panel meeting (Travelling could be required). -Prepare record notes of the meeting -Technical discussions in the regulation panel 2. Regulation communication - Study India Regulation requirements -Study global regulation requirements -Understand the difference in regulation requirements compared to global requirements -Prepare office letters to panel and government agencies. -Technical data collection and comparison Preferred candidate profile Skills Required : - Good knowledge on English & Hindi - Basic Automobile knowledge - Usage of office tools - Others: -Willingness to study technical regulation requirem...