3208 Regulatory Affairs Jobs - Page 29

As a Regulatory Affairs Specialist, you will be responsible for preparing and maintaining Aggregate Safety Reports (ASRs) in compliance with regulatory guidelines. Your key responsibilities will include: - Collaborating with cross-functional teams to gather necessary data and analyses. - Ensuring compliance with applicable regulations and internal policies. - Identifying and assessing safety signals, and reporting findings to relevant stakeholders. - Reviewing and interpreting clinical trial data and safety information. - Assisting in the preparation and submission of regulatory documents to health authorities. - Providing expert advice and guidance on regulatory matters. - Identifying poten...

As a Clinical Research Trainer at our company, you will be responsible for designing, developing, and delivering comprehensive training programs to employees, covering various topics within clinical research principles, data management best practices, and regulatory compliance requirements. Key Responsibilities: - Develop and implement a robust training curriculum aligned with industry standards and regulatory requirements. - Create engaging training materials, including presentations, handouts, and online learning modules. - Design and deliver customized training programs tailored to meet the specific needs of different teams and individuals. - Conduct effective training sessions using vari...

As a Regulatory Medical Writer-Clinical trials (RMW-CT), you are responsible for providing regulatory affairs (RA) strategic document expertise and support to one or more therapeutic areas (TAs) as designated by leadership. You will provide support for the preparation and submission of critical RA documents and responses to health authority (HA) or sponsor information requests using available reference materials such as documentation of previous interactions with HAs and sponsors, clinical development documentation, scientific literature, and content provided by sponsor teams. You may be the lead contact for sponsor or designated HAs interactions with cross-functional teams contributing to t...

About The Role Candidates key responsibilities would include supporting the London Tax team in the following areas quarterly tax provisions and forecasting process for EMEA House entities including the reporting of cash tax payments and the preparation of uncertain tax positions (FIN 48) calculations. annual corporate tax compliance for EMEA House entities, including performing a first level review of the local tax advisors work papers and draft tax returns and partnering with them to ensure the timely submission of all tax filings and settlement of local tax liabilities. preparation and collation of tax data for EMEA House entities in respect of the annual tax reporting requirements for the...

Summary: Are you passionate about optimizing technology landscapes to enhance operational efficiency and drive cost savings? As an Application Rationalization Consultant, you will play a critical role in streamlining our application portfolio, ensuring that each application aligns with business objectives and delivers maximum value. You will collaborate with IT, business stakeholders, and vendors to assess, prioritize, and consolidate applications, driving innovation and efficiency. Join a dynamic environment where your expertise will help shape the future of our technology ecosystem. Detailed Responsibilities: Conduct comprehensive assessments of the current application portfolio to identif...

Job Title: Executive – R&D Biotechnology Business Unit: R&D1 Regulatory Affairs Job Grade G12A Location Baroda 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.” JOB DESCRIPTION The candidate is expected to develop HP...

Completes Compliance Reviews of ingredients, product formulations and finished goods using SAP PLM system for key Asia Pacific markets within specific timelines.

Completes Compliance Reviews of ingredients, product formulations and finished goods using SAP PLM system for key Asia Pacific markets within specific timelines.

Completes Compliance Reviews of ingredients, product formulations and finished goods using SAP PLM system for key Asia Pacific markets within specific timelines.

Manage timely and professional delivery of regulatory activities for relevant products pro-actively to support the business goals including management of rationalization dossiers & related activities for Export products registration/renewal/variation for drug/ food/ other commodities items Represent organization while responding to regulatory agencies queries and other correspondence after engaging and interacting with regulatory bodies of various countries Preparing, submitting, reviewing regulatory file applications and supporting documentation with all registration related tasks post approval authorization, queries, post approval authorization-variations, renewals, fees (Pharmaceutical, N...

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 ...

The ideal candidate brings 15-20 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). Plan resources, ensure statutory compliance, drive traini...

Assistant Manager / Sr. Executive based in Kadi, Mehsana District, Gujarat. 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 improveme...

Chemist (On Contract) (MP 25/20) based in Narmada, Gujarat. The ideal candidate brings 15-20 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...

HVAC & Water System Engineers 2 Posts based in Amritsar. The ideal candidate brings 2 - 4 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)...

HPLC Operator (01 Position) based in Vapi, Gujarat. 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). Ope...

Autocad Operator 1 Pos based in Amritsar. The ideal candidate brings 6-7 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). Operate and tro...

Boiler Engineer (On Contract) (MP 25/19) based in Narmada, Gujarat. The ideal candidate brings 15-20 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/Lea...

QC Head 1 Pos based in Kathua, Jammu & Kashmir. The ideal candidate brings 12 - 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). Mana...

1. Regulatory Affairs: - o Prepare, compile, and submit regulatory dossiers (e.g., CIBRC, CDSCO, EU, etc.) for registration of agrochemical, disinfectants, biocide and food contact material products. o Liaise with client and regulatory authorities for approvals, clarifications, and queries. o Maintain up-to-date knowledge of regulatory requirements in India and international markets. o Support risk assessment and labeling compliance for products. 2. Toxicology & Safety Evaluation: o Review and interpret toxicology, Endocrine disruptors and ecotoxicology study reports. o Coordinate with external labs/CROs for conducting toxicological and ecotoxicology studies. o Maintain regulatory and toxico...

Department : Regulatory Affairs Should be from Pharmaceutical/Lifesciences Industry. Job Overview: We are looking for an experienced and detail-oriented Senior Executive Regulatory Affairs (RA) to join our team. The ideal candidate will be responsible for compiling, reviewing, and submitting regulatory dossiers for both ROW and regulated markets in compliance with EU CTD guidelines. This role demands a strong understanding of global regulatory requirements, coordination across cross-functional teams, and the ability to independently handle client and authority queries. Key Responsibilities : Prepare master dossiers as per EU CTD (Common Technical Document) guidance. Review key regulatory doc...

Job Description Position Summary We are seeking a Senior Officer- Regulatory affairs (US Markets ) to join our team, he will be reporting to Deputy General Manager in this role, you will be responsible for Dossier compilation, preparation, Life cycle management, Pre approval, Post approval Key Responsibilities: Collate/prepare and file dossiers in a timely and accurate manner for formulations/ drug products to get licenses from targeted markets. Prepare the checklist for documentation for regulatory filings as per current regulatory requirements (country specific). Collate and conduct review/overview of relevant standard technical documentation like stability, TTD, PDR, method validations, E...

We are looking for a skilled Income Auditor to join our team, with 3-6 years of experience in the hospitality industry. The ideal candidate will have a strong background in auditing and financial analysis. Roles and Responsibility Conduct audits to ensure compliance with financial regulations and standards. Analyze financial data to identify trends and areas for improvement. Develop and implement audit plans and procedures. Collaborate with cross-functional teams to resolve audit findings. Prepare and present audit reports to management. Identify and mitigate risks associated with financial transactions. Job Requirements Strong knowledge of accounting principles and financial regulations. Ex...

Candidates should be from Nutraceuticals Background Or API Industry Only preferred Female Candidate . Preferred from Western Line of Mumbai RESPONSIBILITIES & ACCOUNTABILITIES Principle accountabilities are assisting in Regulatory Fillings . This involves, manageable knowledge on the regulatory and quality guidelines from various regulatory agencies FASSI (Nutraceuticals) ,ICH, FDA, etc. Should have hands on experience on eCTD regulatory submission tools. Filling of regular amendments and annual updates to regulatory agencies. And complete life cycle management of existing filled products. Handling customer and regulatory queries as per requirement. Participation in the cross functional team...