65 Dossier Jobs - Page 2

Preparation & Review of dossier in CTD, ACTD, ETCD format Preparation of dossiers of stability Data, Analytical method validation Preparing the SPC/SMPC as per country guidelines Preparation and Reviewing of documents COA as per the country guideline

Roles and Responsibilities Prepare dossiers for regulatory submissions (ANDA) according to US FDA guidelines. Manage CMC sections of ANDA applications, including formulations and OSD products. Coordinate with cross-functional teams for dossier preparation and submission. Ensure compliance with regulatory requirements throughout product lifecycle management. Maintain accurate records and databases related to regulatory affairs activities.

We are looking for a good candidate for DRA , candidate should have minimum of 15 yrs of regulatory countries dossiers preparation experience. Candidate should be from injectable unit.

We are seeking a QA-RA Executive to join our dynamic team. The ideal candidate will be responsible for the preparation, compilation, and submission of regulatory dossiers as per CTD/ACTD/eCTD, country-specific regulatory requirements. The role will also involve supporting the QA-RA team in various regulatory tasks and ensuring compliance with applicable regulations and standards. Key Responsibilities: Dossier Preparation and Submission : Responsible for the preparation, compilation, and submission of assigned regulatory dossiers in line with CTD/ACTD/eCTD formats, country-specific requirements for regulatory agencies. Regulatory Compliance : Ensure compliance with regulatory guidelines, ensuring all submissions meet quality standards and deadlines. Additional Tasks : Perform any other tasks as assigned by the reporting manager or senior team members. Backup and Reporting : In the absence of the primary responsible person, handover responsibilities will be managed to a designated colleague. Functional reporting to be done as per the department's organogram. Qualifications: Educational Background : B.Pharma , M.Pharma , B.Sc , or M.Sc in a relevant field. Experience : Minimum 1 year of experience in a regulatory affairs or quality assurance role. Maximum 5 years of experience in a similar position, preferably in the pharmaceutical or healthcare device industry. Technical Skills : Knowledge of Dossier preparation according to CTD/ACTD/eCTD guidelines. Strong understanding of regulatory requirements in healthcare, pharmaceutical, or medical device industries. Desired Skills: Strong attention to detail and high levels of accuracy. Ability to work efficiently under pressure and manage multiple tasks. Excellent communication skills (both written and verbal). Team player with a proactive attitude and problem-solving ability.

Job Description: Executive- Regulatory Affairs- ANDA -(US Market) Responsible for ANDA Submission Responsible for providing support and regulatory guidance to a team in the completion of projects supporting regulatory submissions. Provide regulatory expertise to scientists and senior management on new product development, and assist with the preparation and submission of regulatory documentation Support the maintenance of regulatory files. Strong knowledge of dossier preparation, compilation, and submission guidelines for various regions including Markets. Experience working on ANDAs, CTDs, injectables, Orals and other regulated products. If interested Kindly share your updated CV on khyati@bvrpc.com

Introduction: Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S. Bhartia and Mr. Hari S. Bhartia with strong presence in diverse sectors like Pharmaceuticals, Life Science Ingredients, Contract Research and Development Services, Therapeutics, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Group has global presence employing around 42,000 people across the globe with over 2,400 in North America. Jubilant Pharmova Limited Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radio pharma, Allergy Immunotherapy, CDMO Sterile Injectable, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses. In the Radio pharma business, the Company is involved in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US. The Company's Allergy Immunotherapy business is involved in the manufacturing and supply of allergic extracts and venom products in the US and in some other markets such as Canada, Europe and Australia. Jubilant through its CDMO Sterile Injectable business offers manufacturing services including sterile fill and finish injectable (both liquid and lyophilisation), full-service ophthalmic offer (liquids, ointments and creams) and ampoules. The CRDMO business of the Company includes the Drug Discovery Services business that provides contract research and development services through two world-class research centres in Bangalore and Noida in India and the CDMO-API business that is involved in the manufacturing of Active Pharmaceutical Ingredients. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and autoimmune disorders. The company operates six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. Find out more about us at www.jubilantpharmova.com . The Position Organization- Jubilant Pharmova Limited Designation - Deputy Manager / Manager - Regulatory Affairs Location- Nanjangud, Mysore Responsible for following activities of Head -Technical Services, Design and Engineering Department: Preparation/review and submission of new dossiers and updates for global markets. Preparation/review and submission of responses to queries from regulatory authorities/customers. Provide technical regulatory support to CRD for various activities (route of synthesis, starting material designation, specifications design, applied testing methodologies, Analytical method validations) related to new product development and other regulatory issues as they arise. Review of R and D technical packages for new product development (NPD) as well as cost/quality improvement process (CIP/QIP) for regulatory adequacy. Coordination with R and D to discuss on process and product controls, quality, patent and special studies to respond the queries from regulatory authorities/customers. Tracking of activities status to meet the timeline for new Submissions, Responses and Life cycle management of Dossiers. Preparation/review and submission of technical packages and open parts as per customer requirement. Review of technical packages for out sourced starting materials and intermediates for regulatory adequacy.; Review of analytical method validations, characterization data, process validations, analytical data, specifications/test methods, BMRs, packing material details, and stability data etc. w.r.t. regulatory adequacy for dossier compilation. Review of CSO/stability protocols [EDMS] and change controls (track-wise) related to facility, manufacturing process and control of materials etc. for regulatory adequacy. Attending to and lsquo;on the job trainings' and and lsquo;off the job trainings'. Updating health authority new guidelines to Regulatory affairs team. Person Profile. Education Qualification: MSc / M.Pharma,/ B.Tech / M.Tech Chemical Engineering Experienc e Range : 10+ years in API Regulatory Affairs Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances. To know more about us, Please visit our LinkedIn Page- https://www.linkedin.com/company/jubilantpharmova/mycompany/

Introduction: Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S. Bhartia and Mr. Hari S. Bhartia with strong presence in diverse sectors like Pharmaceuticals, Life Science Ingredients, Contract Research and Development Services, Therapeutics, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Group has global presence employing around 42,000 people across the globe with over 2,400 in North America. Jubilant Pharmova Limited Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radio pharma, Allergy Immunotherapy, CDMO Sterile Injectable, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses. In the Radio pharma business, the Company is involved in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US. The Company's Allergy Immunotherapy business is involved in the manufacturing and supply of allergic extracts and venom products in the US and in some other markets such as Canada, Europe and Australia. Jubilant through its CDMO Sterile Injectable business offers manufacturing services including sterile fill and finish injectable (both liquid and lyophilisation), full-service ophthalmic offer (liquids, ointments and creams) and ampoules. The CRDMO business of the Company includes the Drug Discovery Services business that provides contract research and development services through two world-class research centres in Bangalore and Noida in India and the CDMO-API business that is involved in the manufacturing of Active Pharmaceutical Ingredients. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and autoimmune disorders. The company operates six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. Find out more about us at www.jubilantpharmova.com . The Position Organization- Jubilant Pharmova Limited Designation - Deputy Manager / Manager - Regulatory Affairs Location- Nanjangud, Mysore Responsible for following activities of Head -Technical Services, Design and Engineering Department: Preparation/review and submission of new dossiers and updates for global markets. Preparation/review and submission of responses to queries from regulatory authorities/customers. Provide technical regulatory support to CRD for various activities (route of synthesis, starting material designation, specifications design, applied testing methodologies, Analytical method validations) related to new product development and other regulatory issues as they arise. Review of R and D technical packages for new product development (NPD) as well as cost/quality improvement process (CIP/QIP) for regulatory adequacy. Coordination with R and D to discuss on process and product controls, quality, patent and special studies to respond the queries from regulatory authorities/customers. Tracking of activities status to meet the timeline for new Submissions, Responses and Life cycle management of Dossiers. Preparation/review and submission of technical packages and open parts as per customer requirement. Review of technical packages for out sourced starting materials and intermediates for regulatory adequacy.; Review of analytical method validations, characterization data, process validations, analytical data, specifications/test methods, BMRs, packing material details, and stability data etc. w.r.t. regulatory adequacy for dossier compilation. Review of CSO/stability protocols [EDMS] and change controls (track-wise) related to facility, manufacturing process and control of materials etc. for regulatory adequacy. Attending to and lsquo;on the job trainings' and and lsquo;off the job trainings'. Updating health authority new guidelines to Regulatory affairs team. Person Profile. Education Qualification: MSc / M.Pharma,/ B.Tech / M.Tech in Chemical Experience Range : 6+ years (in API Regulatory only) Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances. To know more about us, Please visit our LinkedIn Page- https://www.linkedin.com/company/jubilantpharmova/mycompany/

We are looking for Regulatory Affairs - Officer / Sr. Officer handling Reg, CIS, Africa and Asia and will be based at Juinagar, Navi Mumbai. Roles & Responsibilities: 1. Dossier Preparation and Submission: Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. 2. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. 3. Regulatory Compliance and Updates: Stay informed of changes in Asian and CIS market regulations, ensuring timely implementation of updates to maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. 4. Documentation and Record Keeping: Maintain well-organized records of submissions, communications, and approvals. Use regulatory software and systems for document tracking, version control, and report generation. Education: B pharm and MBA (Preferred) Desirable Skills & Competencies: Strong communication skills for effective client and team interactions. Excellent negotiation skills to close profitable deals. Strategic thinking for market expansion and business growt Interested candidates can apply or mail your resume. If you have good references you can share - Thanks & Regards, Vaibhavi Behere HR Department Titan Laboratories Pvt Ltd vaibhavi.b@titanpharma.com

- Must have good knowledge of Regulatory Submissions and Research - Must be familiarity with chemical industry specific regulations and guidelines. - Prepare and submit regulatory documents, such as INDs, NDAs, and MAAs, to regulatory agencies Required Candidate profile - Ensure company products with relevant regulatory requirements such as USFDA, FDA, EMA, and local regulations. - Stay up-to-date with changing regulatory requirement to internal stakeholders.

To prepare Standard Operating Procedures of all departments. To review batch manufacturing records protocols and reports of all Active Pharmaceuticals Ingredients and Intermediates to support DMF / FILING. Follow quality assurance systems as per cGMP guidelines. To ensure that all manufacturing operations at the location comply with ICH Q7 system, documentation and records. To follow a system for releasing or rejecting all APIs. To follow up a system for releasing or rejecting intermediates for use outside the control of the manufacturing company. To follow a system to release or reject RM, Intermediates, packing and labeling materials. To perform product quality review. To prepare product labels and establish a system to control issuance of labels. To review raw data of analysis before release of the batch. To support Asst. Manager / Officer for Q.A activities like qualification, validation, calibration, and area monitoring. To prepare documents for customer questionnaires and support. To prepare, review and respond to the Regulatory Query. To fill the customer vendor questionnaire as per customer requirement & provide VQ related declaration. To prepare & review the DMF as per the pharmacopeia & customer requirement. To Submit the DMF to the Regulatory Authority as per the Regulatory requirement. To prepare & review declaration as per customer vendor questionnaire requirement. To perform Nitrosamine risk assessment as per the guideline requirement. To perform Genotoxic risk assessment as per the guideline requirement.

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Administrative documents requirements (COPP, Mfg. License and Import License) . Registration information management system updates on regular basis.

JOB SUMMARY: The role is part of the Global Regulatory Function, responsible to prepare qualitative, error free product registration dossiers for different geographies. JOB RESPONSIBILITIES: Compiling, organizing, and reviewing documentation required for regulatory submissions. Ensuring compliance with relevant regulations and guidelines, collaborating with cross-functional teams, and managing timelines to meet submission deadlines. Attention to detail, knowledge of regulatory requirements, and effective communication skills are crucial for success in this role. REQUIRED EDUCATION AND EXPERIENCE: Min 5 years of relevant experience in Agri industry M.Sc. (Agriculture, Chemistry, Toxicology) MS office skills (Word, Excel, PowerPoint) Excellent written and verbal skills, high attention to detail

Looking For Junior & Senior Regulatory Affair Officer - Preparing dossiers as per country specific guidelines Junior : - 1 - 3 Years ( Vadodara Location) Senior : - 3 - 5 Years ( Vadodara Location) Salary will be Based on Experience

Department - Regulatory Affairs Designation - Sr. Officer No. Of Vacancy - 2 (1 Male/ 1 Female) Qualification - M.Pharm Required Experiance - 2 3 Years/2 5 Years Key Roles ( As per JD) Prepare Dossier According the Guidelines Co Ordinate & Communication with Business Development team regulatory Compliance Review all DMF, F&D, QC, Production & Packaging Department Documents and API Manufacture Documents for Prepare Dossier Checking and Approvals for Artwork for Different Countries including Contract Manufdacturing Prepare and submission of COPP, FSC and Product Permission in FDCA. Industry - Pharma(Injectables) Regards, Darshana cv.naukri@evokehr.com

Ensure that submission of CTD, eCTD, aCTD dossiers. Meet all regulatory requirements. Participate in contacting competent authorities for respective products. Preparation of regulatory submissions (Dossier, Variations) to authorities. Required Candidate profile Should have deep knowledge of Preparation and submission CTD, eCTD and ACTD Dossiers to ROW drug regulatory authorities. Should be able to handle queries, Artworks check, regulatory planning.

As a Regulatory Affairs Specialist at Lifesigns, you will be responsible for regulatory submissions, compliance, and documentation to ensure adherence to medical device regulations across jurisdictions. You will assist in maintaining regulatory files, managing product registrations, responding to regulatory inquiries, and supporting external audits. Your expertise in regulatory approvals, standards compliance, and medical device reporting will be essential in securing and maintaining market access for Lifesigns' solutions. Key Responsibilities Prepare, analyze, and edit technical documents for regulatory submissions in India, the USA, and Northeast Asia. Work with internal teams to ensure compliance with submission requirements and documentation standards. Maintain and update regulatory files, registrations, and listings, including ISO, CDSCO, 510(k), CE dossiers for EU, and NRTL certifications. Support renewals, device listings, site registrations, supplements, and annual reports. Prepare responses to regulatory authority queries within assigned timelines. Stay updated on regulatory procedures, industry guidelines, and compliance changes. Assess device-related incidents/complaints for medical device reporting (MDR) requirements and submit reports as needed. Handle recalls and field actions, ensuring timely reporting to regulatory bodies. Review and approve product labels and promotional materials for compliance with applicable regulations and technical standards. Provide regulatory support during external audits, helping minimize risks of non-compliance. Assist in clinical trial site ethics review board applications and prepare interim or final reports for review boards. Perform other regulatory duties as assigned. Qualifications B.E. in any discipline (preferably BME, ECE, or Mechanical Engineering). 3 5 years of experience in regulatory affairs within the medical device industry. Strong understanding of global regulatory frameworks, including FDA, CDSCO, ISO, MDR, and CE requirements. Experience in regulatory documentation, compliance management, and submission processes. What We Offer Competitive salary and performance-based incentives. Opportunities for professional growth and career advancement. Comprehensive training programs and continuous learning opportunities. A supportive and collaborative work environment. The chance to make a significant impact on healthcare technology compliance.

Job Description: Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per EAEU guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Administrative documents requirements (COPP, Mfg. License and Import License) . Registration information management system updates on regular basis.

Role & responsibilities: Responsible for all Deficiency management of US Market Skill to compile & review ANDAs & their Deficiency responses. Experience of working on IND / 505(b)(2) / Innovations projects for US market. Good analytical and formulation understandings of various dosage forms. Sound knowledge of Regulatory Science and Regulatory Intelligence. Thorough understanding of US ANDAs / GDUFA / ICH guidance. To provide support to cross functional teams to ensure quality and timely submission of the NDA/ANDA/Def. responses. Preferred candidate profile : Must have experience of IRA US market more than 2 years. Critical thinking ability, problem solving skill, regulatory writing skill, and communication skills are very much desired Ready to work at Ahmedabad location. Work from Office only.

Dear Professionals,,! I am Sindhura C , from the Pharma Vertical of Masadir HR Services, an International Recruitment Firm. We have been retained by professionally managed organisation to recruit Regulatory Affairs (RA) Executive for them. The job location is in Vadodara (Gujarat). Qualification: B.Pharm/M.Pharm Experience: Min 4 yrs Must Knowlede of Dossier Making,Product Permission, Application Permission If you are interested in exploring the above opportunity, kindly share your updated resume with me please. In case, if you are not interested, kindly feel free to refer your friends who may be interested in this. Looking forward to hearing from you soon. Thank you! Have a great day! Warm Regards, Sindhura C Associate| Global Talent Acquisition Operations | India Mobile/ WhatsApp : +91 6282564376 Email Id: sindhura.c@masadirservices.com www.masadirservices.com

Expertise in ROW market, understanding nuances in regulatory demands across regions in-depth knowledge of FDA Guidelines to ensure compliance in documentation and submissions. Proficiency in handling technical documents to facilitate accurate and timely submissions Proven ability to review regulatory documents and submissions effectively, ensuring their accuracy and compliance Strong analytical skills to assess regulatory data and provide critical insights for decision-making Experience in dossier preparation, organizing comprehensive documents for regulatory authorities Attention to detail to meticulously handle documentation and regulatory records Excellent communication skills to liaise with regulatory agencies and internal departments Preparation of registration dossiers as pe regulatory guidelines Preparation of renewal application as per renewal guidelines Facilitate query response raised by regulatory authority and customers Preparation and submission of Safety, Quality & administrative variations as per variation guidelines

We are seeking a qualified and experienced Senior Officer/Executive to join our Regulatory Affairs Team. The ideal candidate will specialize in preparing, compiling, and reviewing regulatory dossiers in compliance with international standards and regulatory authority requirements, with a focus on South Africa and other country-specific markets. Roles & Responsibilities: Dossier Preparation and Review: Compile and review high-quality CTD dossiers and variations as per South Africa and other country-specific requirements, including electronic dossier (dB) compilation and publishing. Prepare high-quality eCTD dossiers for new submissions, variations, and responses tailored to regulatory requirements. Agency Communication and Submission: Develop and submit quality responses to agency queries within specified timelines. Collaborate with South African counterparts and principals to validate and electronically publish regulatory documents. Documentation and Compliance: Review and manage scientific and technical documents, including DMFs, CEPs, and drug product-related documents, ensuring adherence to regulatory requirements. Prepare, update, and review product labeling and information. Cross-functional Collaboration: Coordinate with RD&I, manufacturing sites, customers, and principals to gather required documents for dossier compilation. Manage notifications and documentation for implementation of amendments. Regulatory Process Management: Ensure documentation practices align with organizational and regulatory standards. Maintain organized and accurate records for all regulatory activities.Role & responsibilities Requirements: Bachelors or Master’s degree in Pharmacy (B. Pharm or M. Pharm). Proven experience in regulatory affairs, with a specialization in dossier preparation for South Africa or similar markets. Proficiency in electronic publishing tools and CTD/eCTD dossier formats. In-depth understanding of South Africa-specific regulatory guidelines. Strong organizational, communication, and documentation skills. Ability to prioritize multiple projects and meet strict deadlines. Collaborative team player with a proactive and detail-oriented mindset.

We are seeking a highly skilled Business Intelligence Developer to join our team in India. The successful candidate will be responsible for designing, developing, and implementing MicroStrategy BI solutions, including reports, dashboards, and scorecards. The ideal candidate will possess strong analytical skills, excellent communication abilities, and a keen eye for detail. A bachelor's or master's degree in Computer Science or a related field is preferred. Proficiency in SQL, Teradata, and HQL is also required. To succeed in this role, you must be able to work collaboratively with cross-functional teams, demonstrate strong problem-solving skills, and stay up-to-date with the latest MicroStrategy features and functionality.

Job Summary:- Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations: a.Prepare and review variation , Annual notification and labelling approval for US and OAM b. Review of change control and file variation as per country requirement 4. Regulatory compliance: a. eCTD compilation b. Ensure reposition of comprehensive product information into central repository C. Review regulatory filing impact of variations, change controls, etc

Looking candidates for Regulatory Affairs-South Africa Market Experience : 7 -13 Years Job Location: Andheri Mumbai Qualification: M. Pharm/ B.PHARM+PG IN RA Job Description: 1. Management of product lifecycle for South Africa Market. 2. Dossier Preparation 3. Query Response 4. Post Approval changes 5. Variation Filing 6. Coordination with cross functional team 7. Module 1-5 8. Preparation and compilation of administrative, quality & Safety application (Eg. Type IA,IB Type II) 9. Reviewing Product information as per QRD Requirement 10. Should have strong knowledge of CTD dossier and must have experience of team handling. 11. Risk Assessment and Mitigation: - Identify potential regulatory risks, develop mitigation plans and adapt strategies accordingly to minimize risks. 12. Provide regulatory guidance and support to other departments as needed. Thanks & Regards Mayuri

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English - Expert 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 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 by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs tasks of building regulatory dossiers of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.You will be expected to collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for? Life Sciences Regulatory Services Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Agility for quick learning Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualifications Master of Pharmacy