323 Ectd Jobs

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Language - Ability: English(International) - Intermediate About Accenture 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 countries. Visit us at www.accenture.com What would you...

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Document Management Systems (DMS) Good to have skills : NAMinimum 3 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 are optimize...

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 EWM Good to have skills : NA Minimum 5 year 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 problem-solving act...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Sr Analyst Qualifications: Master of Pharmacy Years of Experience: 5 to 8 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 improve outcomes b...

Coordinate and prepare regulatory submissions, including applications, reports, and other documents.Ensure compliance with relevant laws, regulations, industry standards.Develop and maintain relationships with regulatory authorities Required Candidate profile Strong knowledge of regulatory submissions, compliance, and industry standards.Excellent communication and interpersonal skills.Ability to work independently and as part of a team.

Coordinate and prepare regulatory submissions, including applications, reports, and other documents.Ensure compliance with relevant laws, regulations, and industry standards. Required Candidate profile Strong knowledge of regulatory submissions, compliance, and industry standards.Excellent communication and interpersonal skills.Ability to work independently and as part of a team.

8 years experiences for RA role in medical device and or pharmaceutical industry.Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements. Required Candidate profile Desired Skills:RA role in medical device, US FDA and EU. Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare related majors.

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 for Utilities CRM 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 pr...

Publish regulatory submissions to relevant authorities, ensuring compliance with required standards.Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Required Candidate profile Strong understanding of regulatory requirements and guidelines governing submissions. Excellent publishing skills, including attention to detail and ability to meet deadlines.

Collaborate with internal stakeholders to resolve issues related to regulatory submissions.Stay updated with changes in regulatory requirements and implement necessary updates to publishing processes. Required Candidate profile Experience in regulatory submissions publishing, preferably in the employment or recruitment industry. Strong understanding of regulatory requirements and guidelines governing submissions.

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Master 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 improve outcomes...

About The Role Skill required: Provider Network - Life Sciences Regulatory Operations Designation: Health Operations Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 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 r...

Coordinate and prepare regulatory submissions, including applications, reports, and other documents.Ensure compliance with relevant laws, regulations, and industry standards.Develop and maintain relationships Required Candidate profile Strong knowledge of regulatory submissions, compliance, and industry standards. Excellent communication and interpersonal skills. Ability to work independently and as part of a team.

Develop high-quality regulatory documents, including clinical trial applications and marketing authorizations.Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Required Candidate profile Minimum 2 years of experience in regulatory medical writing or a related field. Strong knowledge of regulatory requirements, including FDA, EMA, and ICH guidelines.

Responsibilities: Compilation and review of regulatory dossiers (CTD, ACTD, eCTD) for CIS, LATAM (especially Brazil & Mexico), African, and EU regions. Handle full lifecycle of product registration including new submissions, renewals. Review technical documentation: PDR, DMF, AMV, BMR/BPR, Specifications, Stability Reports, BE Studies, etc. Address Ministry of Health (MoH) queries and manage deficiency responses. Manage post-approval changes and variation submissions. Liaise with international regulatory agents and distributors for submission coordination. Artwork review and approval ensuring compliance with label regulations. Maintain up-to-date registration database and submission tracker....

Publish regulatory submissions to relevant authorities, ensuring compliance with required standards. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Required Candidate profile Strong understanding of regulatory requirements and guidelines. Excellent communication and coordination skills. Ability to work independently and as part of a team.

This is an exciting role and would entail you to • Oversee the end-to-end submission process of materials to the MLR review platform (Veeva Vault Promo Mats) • Understand and document client-mandated submission requirements and ensure these protocols are maintained with guidance from MLR/Submission managers • Create, uphold, and maintain submission checklists for assigned brands and ensure accurate and timely MLR submissions into Client systems • Maintain a comprehensive and accurate record of all current and upcoming submissions including the stage of review, job codes, references, and deadlines • Annotate any notes/comments relevant to MLR reviewers onto the submission file (As required, f...

SR. Executive/Assistant Manager/Manager - Regulatory Affairs Roles and Responsibilities - To prepare dossiers as per CTD/ACTD guidelines for product registration, renewal & variation applications to submit in regulated / semi regulated countries. - To arrange administrative documents required for dossier submission & export purpose (Manufacturing Lic, WHO-GMP, P.P/COPPs/FSC- Procuring and legalization). - To check & approve the artworks for regulated / semi regulated countries. - To Co-ordinate and follow-up with manufacturer for documents & samples/WS required for regulatory submission. -Handling queries pertaining to regulatory submissions from various regulatory authorities. - Maintain re...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 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 client...

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...

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...

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 Enablon Software Platform 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 development aligns with business objectives, overseeing project timelines, and facilitating communication among stakeholders to dri...

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: 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...

As a Regulatory Affairs Specialist in our company, your role will involve the following key responsibilities: - Ensuring timely response to deficiencies raised by Agency on ANDAs. - Reviewing all specifications and proposals from sites of approved ANDAs for supplement filings. - Providing regulatory support and reviewing pre-filing and development documentation such as development reports, BMR, BPR, specifications, method validation, process validation, change control, etc. - Authoring, compiling, and reviewing ANDA dossier in eCTD format and structured product labeling (SPL), followed by publishing, validation, and submission of the dossier. - Submitting PADER to comply with USFDA requireme...