3208 Regulatory Affairs Jobs - Page 30

Role Overview: As a Medical Affairs Executive, your primary responsibility is to understand current practices, medicines, and trends in the respective therapeutic area by engaging in doctor visits, attending scientific symposia, and reviewing key therapeutic journals. This knowledge will enable you to provide valuable information to both internal and external customers. Key Responsibilities: - Publish scientific articles related to company products. - Create presentations for doctors for Continuing Medical Education (CME) sessions and product launches. - Participate in implementing the medico-marketing strategy. - Conduct regular field visits to doctors for product management and Key Opinion...

Role Overview: As a RA Associate I at the company, you will be responsible for preparing and revising high-quality US Gx labeling documents filed under an ANDA and/or 505(b)2. You will ensure adherence to federal regulations and meet deadlines to align with company goals. Your role will involve developing compliant Structured Product Labeling (SPLs) files with complete drug listing information. Key Responsibilities: - Develop US labeling documents for assigned ANDAs and/or 505(b)(2)s, ensuring alignment with company goals and submission requirements while meeting all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents. - Establish SPL for assig...

Role Overview: As the Regulatory Compliance Manager based in Delhi, India, your primary responsibility will be to ensure the company's compliance with SEZ, Custom (MOOWR, AEO, SVB), DGFT, and FSSAI regulations. You will be tasked with obtaining permissions from Custom authorities, implementing compliance mechanisms for MOOWR and AEO, and liaising with Custom and SEZ authorities to secure timely permissions for Laureate's clients. Key Responsibilities: - Ensure compliance with SEZ, Custom (MOOWR, AEO, SVB), DGFT, and FSSAI regulations - Obtain permissions from Custom authorities - Implement compliance mechanisms for MOOWR and AEO - Liaise with Custom and SEZ authorities to secure timely permi...

Role Overview: As the Pharmacovigilance Country Head at Bayer in India, Nepal, Bangladesh, Bhutan, and Sri Lanka, you will be responsible for ensuring the safe and appropriate use of the company's products while working towards excellence. Your main duties will involve leading and managing the PV team in the mentioned countries, overseeing the Safety Management Team, providing guidance on PV and safety matters, representing Bayer's PV system locally, and ensuring compliance with laws and regulations related to patient safety and product licensure. Additionally, you will conduct education and training on PV topics within the local organization. Key Responsibilities: - Leading and managing the...

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...

Role Overview: As a Regulatory Affairs Associate at Teva, you will be a project manager responsible for the Regulatory Affairs lifecycle management on Medis dossiers for Teva's 3rd party client business (Medis). Your main task will involve ensuring that information flow and provision of supportive documents reach the clients. You will be liaising with Teva's 3rd party client business (Medis) supply chain, Teva site RA, and other relevant functions. Your role will focus on lifecycle management of specific products for Europe and the international market, ensuring regulatory modules under your responsibility are up to date and in accordance with agreed procedures. Key Responsibilities: - Infor...

As a member of the team, you will play a crucial role in achieving exceptional business outcomes by effectively leading your team. Your responsibilities will include: - Utilizing your writing skills to craft narratives for adverse events and product complaints during intake, as well as developing customized responses for medical inquiries. - Handling customer requests through various channels such as phone, email, CRM, and chat platforms. - Identifying adverse events and product complaints during customer interactions, conducting intake procedures to generate compliant reports in accordance with EVERSANA-MICC and client SOPs. - Demonstrating knowledge of FDA post-marketing adverse event repo...

The Opportunity As a Compliance Engineer, you will be responsible for ensuring that our products meet product material regulations You will collaborate with cross-functional teams like Portfolio and Product Management, Engineering, SCM and regulatory authorities to drive compliance initiatives and minimize risk related to product material compliance against various regulations How You'll Make An Impact Deliver product information to iPoint Systems, including the Product Bill of Materials (BOMs) with detailed part and supplier data, and conduct high/low-risk parts analysis based on Material Data File (MDF) category risk assessments. Collaborate with the Engineering team and Portfolio and Prod...

As a Manager 1 at Sun Pharma Laboratories Ltd in Guwahati - Regulatory Affairs, your role involves facilitating the harmonization and consistent implementation of Quality System and procedures at the site in alignment with Corporate Quality Policies/Procedures. Your responsibilities include: - Reviewing documents related to Quality Management System (QMS) & Compliance - Ensuring compliance of Quality Management System - Attending Site Training Program as per site training program and Global Quality Standards requirements - Submitting dossier documents after review against requests received from Corporate regulatory affairs - Responding to queries for submitted dossier against requests receiv...

Summary Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment. About The Role Key Responsibilities Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COA's and other regulatory documents as per the needed) to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders: NTO, Reg CMC, Global labelling & RA Ops for renewals...

Role Description This is a full-time, on-site role for a Regulatory Affairs Manager located in Roorkee. The Regulatory Affairs Manager will be responsible for ensuring compliance with regulatory requirements, overseeing regulatory submissions, and maintaining the quality system. The role involves monitoring and interpreting regulatory changes, developing regulatory strategies, and providing regulatory guidance throughout product development and manufacturing. Qualifications Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs skills Experience with Regulatory Submissions Knowledge of Quality System regulations Excellent written and verbal communication skills Attention to d...

Responsibilities Develop and implement strategies for obtaining regulatory approvals for real estate projects in Mumbai Collaborate with internal teams to ensure all project plans align with regulatory requirements Liaise with government agencies and regulatory bodies to expedite approval processes Monitor and track the progress of approval applications and address any issues or delays Stay up-to-date on changes in regulations and ensure compliance across all projects Prepare and submit necessary documentation and reports to regulatory authorities Coordinate with legal teams to review agreements and contracts for compliance Provide guidance and support to project teams on regulatory matters ...

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.

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-...

About The Role Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Appian Process Automation Good to have skills : NAMinimum 2 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will engage in the design, construction, and configuration of applications tailored to fulfill specific business processes and application requirements. Your typical day will involve collaborating with team members to understand project needs, developing innovative solutions, and ensuring that applications funct...

Hiring for a MNC company which is into chemical. Intrested can share cv on- sonam.thakur@cielhr.com Key Responsibilities: Regulatory Affairs & Product Safety Develop new SDS in coordination with external consultants, ensuring accurate information gathering, review, corrections, and customization. Handle customer queries related to SDS regulations and update SDS as required. Periodically review and update SDS in line with regulatory changes and organizational requirements. Perform administrative amendments to SDS for shipping and logistical compliance. Administer and maintain the online SDS portal. Monitor global regulatory changes affecting SDS and ensure compliance. Prepare TREM cards and E...

Job Title : Infrastructure Lead Job Grade: G11A Function: Global Information Technology Sub-function: Manufacturing & Quality IT Manager’s Job Title: Manager-2 Skip Level Manager’s Title: SGO India Cluster 2 IT Lead Function Head Title: Global Chief Information Officer Location: Baska No. of Direct Reports (if any) 0 Date of Joining: Areas Of Responsibility At Sun Pharma, we commit to helping you “ Create your own sunshine ”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous ...

Ruby Chemicals is looking for Specifications Manager to join our dynamic team and embark on a rewarding career journey. Define and maintain technical product specifications ensuring alignment with business and compliance needs. Collaborate with engineering and design teams to translate functional requirements into product specifications. Manage version control, validation, and documentation of specifications across product lines. Support audit readiness, standardization, and product improvement initiatives. Disclaimer : This job description has been sourced from a public domain and may have been modified by Naukri. com to improve clarity for our users. We encourage job seekers to verify all ...

What you will do In this vital role you will conduct complex complaint investigations, resolves corrective actions with their effectiveness and resolves steps necessary to ensure the proper level of control for product in distribution. We are seeking a Specialist Quality Complaints Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current...

What you will do In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role is for a technical functional lead/developer with Clinical Risk Based Monitoring (RBM) / Risk Based Quality Management (RBQM) system implementation. The role involves working closely with product managers, designers, and other engineers to build high-quality, scalable software solutions. Roles & Responsibilities: Participate in technical discussions related to the RBSE system(s) within Clinical Trial Management, Monitoring, and Engagement...

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA CMC and is seeking to expand its capacity in India . The Regulatory Compliance team performs assessment of operational changes for regulatory reportability and maintains state and federal licenses for Amgen products across phases of development, modality, and countries. The team member will be responsible for maintaining U.S. state and federal com...

Sr Manager - Gen Med Biosims International Regulatory Lead The Senior Manager of Regulatory Affairs at Amgen oversees regulatory compliance initiatives within the company. They are responsible for ensuring all company procedures and products adhere to state and federal regulatory requirements. Group Purpose International Regulatory Affairs provides regulatory leadership/ expertise for the development, registration, and lifecycle management of all Amgen molecules. Job Summary The International Regulatory Lead (Sr. Manager) is assigned to lead one or more Amgen products. The product(s) assigned have complex programs/strategies and high impact to Amgen. Provide Guidance and Leadership on mechan...

The Global Regulatory Policy & Intelligence (GRPI) group at Amgen engages with regulators, industry associations, and other stakeholders externally, and internally it manages regulatory intelligence for GRAAS monitoring, analyzing, and communicating regulatory requirements worldwide to enable fast, efficient global filings. The Senior Manager, as part of this team, plays a pivotal role in executing the regulatory intelligence function. Key Responsibilities: Regulatory Intelligence Deliverables: Contribute to the monitoring and analysis of the global regulatory landscape and develop agreed intelligence deliverables under the supervision of the Regulatory Intelligence Director. This includes p...

ABOUT THE ROLE The Regulatory Affairs Senior Associate role assists US Promotion Regulatory representatives and other cross-functional roles in the administration of regulatory strategies for department initiatives across all product brands. This role assists with preparing, tracking, reporting, and archiving US regulatory documentation, including preclearance and advisory comment promotional materials, and is responsible for all Ad/Promo regulated data management. This role performs the planning and tracking of all US promotional label changes and manages the system update of promotional labeling and Important Safety Information (ISI). This role is responsible for US digital labeling and tr...

Hiring a Unit Operations Head for its greenfield API manufacturing facility API production Ensure compliance with global regulatory standards Lead process improvement & scale-up Manage budget & cost efficiency Lead and develop cross-functional teams Required Candidate profile 18+ years in API/Pharma manufacturing ONLY - Operational Excellence Strong Plant Operations leadership exp, Regulatory Compliance Proven track record with USFDA/MHRA audit Age below 50 years preferred