3208 Regulatory Affairs Jobs - Page 15

Manager - Business Development (Clinical Research) Role and Responsibilities: The Lead - Strategic Business Development will play a crucial role in maintaining strong client relationships, handling clients, and acquiring new clients for our Business Development process. They will be responsible for positioning MakroCare's specialized services with strategic planning and implementation for medical devices and diagnostics companies in Europe and the USA. Additionally, the role involves developing and implementing business development strategies, maintaining international contacts, achieving sales targets, and working with the marketing and pre-sales teams for lead generation. Candidate Qualifi...

Overview As a part of Procurement (S2C) team, manage RFX & Contracting activities, for IT category, covering IT Hardware, Software as well as Services. Ensuring alignment with business needs, delivering cost savings, and driving compliance. The role partners with stakeholders, legal, and suppliers to enable efficient, value-driven, and compliant sourcing. Responsibilities Own Contracting process for low to medium risk IT Hardware, Software & Services projects from stakeholder intake, market scan, RFx setup and execution, to contract negotiation. Drive RFX activities including but not limited to: drafting RFP requirements in partnership with stakeholders, collaborating with suppliers througho...

Overview As a part of Procurement (S2C) team, manage RFX & Contracting activities, for IT category, covering IT Hardware, Software as well as Services. Ensuring alignment with business needs, delivering cost savings, and driving compliance. The role partners with stakeholders, legal, and suppliers to enable efficient, value-driven, and compliant sourcing. Responsibilities Own Contracting process for low to medium risk IT Hardware, Software & Services projects from stakeholder intake, market scan, RFx setup and execution, to contract negotiation. Drive RFX activities including but not limited to: drafting RFP requirements in partnership with stakeholders, collaborating with suppliers througho...

Job Description 3 to 5 years of SAP EHS experience (support/projects) with cross-functional skills (SD, MM). Deliver services in HSE area (both SAP & non-SAP) in solution design, build, testing, implementation and application management services Skills : Strong functional and business process knowledge across all SAP EHS areas like Product Safety, WWI, Dangerous Goods, Product compliance and risk/incident management. Strong understanding of all context e.g. regulatory framework relevant for EHS especially for NA & EU . Knowledge/work experience on non-SAP HSE tools (any Saas tools) is an added preference. Excellent functional and technical understanding of the integration requirements for SA...

Aggregate Report Specialist JOB DESCRIPTION Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title: Aggregate Report Specialist Location: Bengaluru/Mysore - Hybrid Function: Drug Safety DESCRIPTIO...

Role & responsibilities We are hiring Regulatory Associates and Specialists with 2 to 8 years of relevant pharmaceutical ( with finished formulations/OSD) experience to manage the compilation and submission of documents to global markets, including the EU, UK, New Zealand, CIS, GCC, ASEAN, and LATAM. Preferred candidate profile Associates will gain experience by compiling and coordinating with the team on projects and regulatory submissions, gathering documents in accordance with the regulatory requirements for the markets mentioned. Responsibilities include compiling new application and lifecycle management CTD dossier modules, and interpreting and preparing responses to quality and adminis...

Manage Distributor Sales and Application force performance with the support of the Regional Director in his / her territory Support and advise surgeons on the use of our products; Participate to Key account surgeries as defined by Regional Director Establish, develop and maintain KOL relationships within the territory Realizes set sales budget by managing/expanding sales contacts, following-up quotations, special requests and tenders Reports regularly on activities and performances Gather, analyze and share all relevant information on markets development, competition, customers and products in his territory Identify risk/opportunities in the market and propose /execute strategies and action ...

Primary Skills We are seeking a highly skilled Business Analyst with expertise in Murex risk engine configuration and market risk management. The ideal candidate will have hands-on experience in stress testing, Value at Risk (VaR), and related activities within the Murex environment for the past 3 to 4 years. They should possess a strong understanding of risk P&L, with an overall professional experience ranging from 5 to 7 years. Knowledge of MRA (Market Risk Aggregation) and MRE (Market Risk Engine) configurations, as well as familiarity with FRTB (Fundamental Review of the Trading Book), is highly desirable. About The Role - Grade Specific 5+years of experience in financial services, with ...

Job Title: Medical Writer Business Unit: Clinical Research Location: Sun House, Mumbai 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 progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key responsibilities: Develop and update process documents, SOPs and trackers ...

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 count...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/Bachelor Degree in Life Sciences Years of Experience: 1 to 3 years Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on ...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy/Bachelor Degree in Life Sciences Years of Experience: 0 to 1 years Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technol...

About The Role Project Role Software Development Lead Project Role Description Develop and configure software systems either end-to-end or for a specific stage of product lifecycle. Apply knowledge of technologies, applications, methodologies, processes and tools to support a client, project or entity. Must have skills Veeva Vault Good to have skills NA Minimum 5 year(s) of experience is required Educational Qualification 15 years full time education Summary We are seeking an experienced and motivated Team Lead with strong expertise in Veeva Vault RIM (Regulatory Information Management) and data migration projects within the life sciences or pharmaceutical domain. The ideal candidate will le...

Role & responsibilities To assist in developing a clear vision and roadmap to take Havells India Ltd, to the Top 3 in ESG Review and monitor EHS and sustainability program objectives, status and support requirements, to ensure progress in line with the vision, policies and regulations. Assist in developing strategies to address issues such as energy reduction, recycling, plastic waste management, reduction of carbon footprint etc both within the company and with associated partners like vendors, distributors etc. Well versed with international rating standard such as DJSI, MSCI, sustainalytics etc. Collect, analyse and structure data and information w.r.t Sustainability Report, Integrated Re...

Seeking an immediate joiner with 3–8 years’ regulatory experience B.Pharm/M.Pharm. Responsible for CTD/ACTD dossier prep,review,query response,team coordination,regulatory submissions,documentation. Strong R&D,research, communication skills required.

RERA Vision is looking for Compliance Executive to join our dynamic team and embark on a rewarding career journey Regulatory Compliance:Stay abreast of relevant laws, regulations, and industry standards Interpret and communicate regulatory requirements to applicable departments Develop and maintain a comprehensive understanding of the organization's operations to identify areas of compliance risk Policy Development and Implementation:Develop, review, and update compliance policies and procedures Ensure that policies are communicated effectively across the organization Work closely with different departments to integrate compliance requirements into daily operations Training and Education:Con...

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description About the Role We seek a highly skilled Country Approval Specialist to join our Clinical Operations team in India. This outstanding opportunity lets you lead/exel in clinical operations team and collaboration. As a vital team member, you will ensure flawless execution of study startup phase, meeting all regulatory requirements and industry standards. Responsibilities Determine and prepare country-specific submission dossiers for DCGI & EC meeting regulatory requirements for clinical trial submissions. Successfully implement submission strategies to acquire regulatory and ethics committee approvals. Forecast time...

Regulatory Affairs Job Opportunity! Desired Experience : 5- 11 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Senior Executive/ Assistant Manager Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Job Responsibilities: Responsible for Preparation of Regulatory Documents for submission to Indian Regulatory Authorities. Experienced in handling, management and expansion of product portfolios, markets/ territories. Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC. Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, Export NoC,...

SUMMARY Purpose of Job: Support the effective management of company assets throughout their lifecycle, ensuring accuracy, accountability, and compliance. The role focuses on maintaining updated asset records, monitoring utilization, and assisting in the reconciliation of fixed and movable assets. The position is responsible for providing timely and accurate asset-related data to management; assisting in audits. Job Description: Through Google Sheet operate CAPEX PR & PO. Maintain equipment details. Maintain vendor service PO. It is maintained totally through Google Sheet with a variety of reports. Good knowledge of Excel, Word & PowerPoint. Requirements Required relevant experience (Type and...

We are looking for a skilled ENT professional with 5 years of experience to join our team as an Associate in the field of ENT. The ideal candidate should have a strong background in MS - ENT and be able to work effectively in a fast-paced environment. Roles and Responsibility Conduct thorough examinations and diagnoses of patients with various ear, nose, and throat conditions. Develop and implement effective treatment plans for patients with different levels of severity. Collaborate with other healthcare professionals to ensure comprehensive care. Stay updated with the latest advancements and technologies in the field of ENT. Provide guidance and support to junior staff members. Participate ...

JD: 1. Ensure that a company's products comply with the regulations of the Africa regions 2. Keep up to date with national and international legislation 3. Dossier Preparation 4. Managing activities of Regulatory Affairs

Job Description -Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished products for US and IRF market at CMU. -Release of batch manufactured for US and IRF market at CMU -Handling of market complaint with root cause identification and CAPA implementation -Review of documents such as executed BPR, Analytical records, Change Controls, Deviations, OOS, Process Validation, Cleaning Validation, Equipment Qualification, stability data and CAPA for products of US & IRF market. -Provide required documents to Regulatory affairs for variations and updates -Monitoring of process st...

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...

The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Additional info: Key Skills: DMF Compilation, QA Coordinat...

The ideal candidate brings 10- 15 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Lead microbiology practices including EM, MLT, sterility ...