3208 Regulatory Affairs Jobs - Page 28

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to i...

About The Role Skill required: Talent Acquisition - Onboarding Designation: Talent Connector Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsCandidates with End to End Recruitment experience - Domestic/International MarketAdminister onboarding of new employees including all onboarding activities like orientation registration, completion of background check, creation of SAP record, etc. What are we looking for? Written and verbal communicationDetail orientationCritical ThinkingProblem Management" Excellent communication skills, Uses profession...

About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shar...

About The Role Skill required: Talent Acquisition - Onboarding Designation: Talent Connector Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsCandidates with End to End Recruitment experience - Domestic/International MarketAdminister onboarding of new employees including all onboarding activities like orientation registration, completion of background check, creation of SAP record, etc. What are we looking for? Written and verbal communicationDetail orientationCritical ThinkingProblem Management" Excellent communication skills, Uses profession...

About The Role Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP Asset Management Good to have skills : NA Minimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in pro...

About The Role Skill required: Talent Acquisition - Onboarding Designation: Talent Connector Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsCandidates with End to End Recruitment experience - Domestic/International MarketAdminister onboarding of new employees including all onboarding activities like orientation registration, completion of background check, creation of SAP record, etc. What are we looking for? Written and verbal communicationDetail orientationCritical ThinkingProblem Management" Excellent communication skills, Uses profession...

About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shared Serv...

About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shar...

About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shared Serv...

About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shared Serv...

About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shar...

About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shar...

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: BCom/B.B.M Years of Experience: 0 to 1 years What would you do? Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and ratin...

About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shared Serv...

Role Overview: As an Associate Manager / Manager in API Regulatory Affairs - DMF Filing/ Compilation for the global market, your responsibilities will include: - Hands-on experience in Regulatory Affairs-API/DMF Filing/DMF Compilation/ Submission/ Customer Communication. - Compiling and submitting DMFs globally for small molecule APIs in eCTD format, ensuring compliance with ICH and region-specific regulatory guidelines (EU, US, Canada, Japan, Australia, Brazil, China, South Korea, etc.). - Demonstrating good knowledge of all regulatory guidelines and API Regulatory processes. - Compiling responses to queries from Regulatory Agencies & customers globally, meeting specified timelines for subm...

As a Quality Sr Specialist at Teva Pharmaceuticals, you will play a crucial role in ensuring the quality and compliance of active pharmaceutical ingredients (APIs). With over 80 years of experience in the generic API industry, Teva Pharmaceuticals is a trusted global supplier supporting 80% of the top 50 global pharmaceutical companies. Your contributions will directly impact the timely introduction of new products to the market, solidifying Teva's position as a leader in the industry. Key Responsibilities: - Collect, compile, analyze, and review all data for Annual Product Quality Review (APQR). - Process and oversee changes through the entire workflow, including generation, justification, ...

You will be joining an organization with a reputable history of over 10 years in the Pharma raw material industry, specializing in excipient products. As a Regulatory Affairs Associate, you will play a crucial role in handling technical queries and regulatory documentation for the company's newly launched E-commerce platform, CLYZO. - Manage the entire regulatory documents of excipients. - Resolve technical queries from prominent pharmaceutical clients. - Handle technical matters and document-related work for the excipient manufacturer. - Prepare in-house technical documents required for the promotion of excipient products. - Provide specific technical documents for manufacturer and product ...

Role Overview: As a Regulatory Affairs Specialist at the company, your main responsibility will be to prepare, review, and finalize regulatory strategies for complex products such as injectables, ophthalmic, otic, topical gel, DDCP, etc., along with 505(b)(2) products for regulated markets like the US, Canada, and EU. You will be drafting, reviewing, and finalizing various regulatory documents including Pre-ANDA/Pre-IND/ScA/Scientific meeting packages, controlled correspondences, and deficiency responses for complex products. Additionally, you will collaborate with cross-functional teams, meet management expectations regarding timelines and quality, and provide training to new team members o...

Purpose And Scope Responsible for development, implementation, and change control of new and revised local labeling for assigned Astellas products and areas. Ensures compliance with Company Core Data Sheets, applicable regional health authority requirements, and internal procedures and alignment with business needs. Research government initiatives related to labeling and packaging, and assures that Astellas adopts new initiatives according to prescribed timelines. Requires significant interaction outside the Regulatory Affairs department on complex issues and questions. Maintains a positive working relationship with global internal stakeholders and business partners. Responsibilities And Acc...

Role & responsibilities Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports. Under minimal supervision, proactively request documentation required for annual reports, compile and publish for managements review. Under managements direction/assignment, work independently on simple supplements, compile and publish for managements review. Assist management on more complex supplement to gain experience. Further educate oneself on FDA Regulations by reviewing any/all applicable post approval guidances to understand and accurately assess change controls. When needed, train Associate Is on internal processes, procedures, databases and trackers. Other pr...

Job Profile General Manager, India, Abbott Diabetes Care About Abbott: Abbott is a global healthcare leader dedicated to helping people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines. With 113,000 colleagues serving people in more than 160 countries, we are committed to making a lasting impact on global health. About Abbott Diabetes Care: Abbott Diabetes Care is a global leader in diabetes management, dedicated to helping people with diabetes lead healthier, happier lives. Our innovative product portfolio includes the FreeStyle family of glucose monitoring systems, which provid...

Role Overview: As an experienced Regulatory Affairs Specialist with a strong educational background in M. Pharmacy, you will be responsible for various key activities related to regulatory affairs in the pharmaceutical industry. Your expertise in regulatory activities such as CTD dossier preparation, query solving, and thorough knowledge of ICH guidelines will be crucial for the successful submission of dossiers to regulatory authorities. Key Responsibilities: - Prepare and submit new dossiers in compliance with regulatory requirements - Conduct gap analysis of dossiers to ensure completeness - Compile dossiers in eCTD format for submission to regulatory authorities - Coordinate the submissi...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Regulatory Affairs Specialist In this exciting role as a Regulatory Affair Specialist, you will have responsibility for developing and implementing compliant regulatory processes within the Surgical OU Regulatory organization. Operating Unit Our Surgical OU is one new, powerful operating unit bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics. We'll approach the market with a unified approa...

Role Overview: As an ideal candidate for this position, you should have experience in handling a wide range of Ayurvedic/Herbal/Nutraceuticals Products including Cosmetics. Your role will involve providing vital and key support to various departments such as Manufacturing, QA, QC, Regulatory Affairs, Supply Chain Management, Contract Manufacturing, and others. Key Responsibilities: - Design and develop new products, and be well-versed in scaling up exercises - Conduct Cost Reduction Studies and oversee Transfer of Technology processes - Manage technical areas including Process Development, Trouble Shootings, and Reformulation Studies - Conduct Competitive Market Product Studies and perform C...

Job Overview Responsible to provide support lab compliance activities. Summary Of Responsibilities These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual contributor globally. Review and approval of documents such as but not limited to protocols and report for Method qualification, method validation, transfer; methods; investigations. Handling of Quality Issues, Corrective/Preventive Actions, and Change Controls related to the client as well as their contract laboratories Works with the supported departments to maintain and continuously improve the quality culture to posit...