490 Anda Jobs

Maintain up-to-date launch trackers (OSD, Injectable, Ophthalmic, and CMO projects) Coordinate with Cross-functional teams (CFTs) Drive NPL meetings and sharing minutes of meeting Prepare presentations for tracking and reporting purpose Follow up on all action items from the meetings and ensure all action items are closed in a timely manner Material management and real-time tracking on all inputs required to manufacturing process Track manufacturing, packaging, and release status for NPLs Collaborate with Regulatory Affairs on ANDA approval progress and post approval supplement filing Communicate across all stakeholders and upper management to inform on the project status, critical path item...

Skills Required : Ensuring contract compliance, mitigating legal risks, and resolving disputes to protect the company's interests NICMAR WITH Civil background is mandatory. Key Responsibilities Administer the Contract Life Cycle Management which includes pre award and Post award Contract Management. Understand and analyze the complete scope of work, in terms of technically and contractually. Review of regular correspondence with Client with respect to all the contractual and on any other site related issues. Ensuring compliance with all contractual & statutory requirements of the project till closure. Formulating claims for variations, price escalation, extension of time, compensation for ex...

Role & responsibilities: To Preparation and review of clinical study reports along with preparation of Bio summary/summary tables, BTIF and other regulatory documents with the study data. To search for submission documents, understanding the regulatory requirements and provide the documents. Adhering to GCP to meet regulatory requirements, Verification of deviations from the Protocol, SOPs, GCP and other applicable requirements and taking preventive action and corrective action to prevent recurrence. Preparation of audit reports and suitable corrective and preventive action plans. To review Standard Operating Procedures to check for compliance with regulatory requirements. To have experience...

Role Overview: As a Regulatory Affairs Manager, you will be responsible for monitoring the company's production activities to ensure compliance with applicable regulations and standard operating procedures. Your key responsibilities will include devising regulation compliance strategies, creating training programs for staff, conducting internal inspections, and staying updated with the latest rules and regulations. Key Responsibilities: - Possess in-depth technical knowledge of CMC aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents in line with regulatory guidelines, evaluate changes in CMC documentati...

Job Title: Manager 1 - Packaging & Device Development Business Unit: R&D1 Regulatory Affairs Job Grade G10 Location Vadodara 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 SunshineAs 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: 1. Characterization of RLD pack samp...

About The Role Job Title – Insurance + Analyst/Consultant/Manager + S&C Management Level:Analyst/Consultant/Manager Location:Gurugram/Mumbai/Bengaluru Must have skills:Insurance + Generic + Guidewire/Duckcreek + Consulting Good to have skills:Insurance + Generic + Guidewire/Duckcreek + Consulting Experience :5 to 15 years Education qualification :Graduation + Post graduation About The Role Analyst/Consultant/Manager - Insurance Find endless opportunities to solve our clients' toughest challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice:Industry Consulting, GN S&C I Areas of Work:Insurance (core) Explore an Exciting Career at Acce...

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Sea...

Overview Support Europe presentation beautification and standardization. Responsibilities Presentation Support Graphic support standard design request from BU Qualifications Applicable experience in presentation support and educational background from design.

We are looking for a highly skilled and experienced Regulatory Affairs professional to join our team at Niva Bupa Health Insurance. The ideal candidate will have a strong background in regulatory affairs and excellent analytical skills. Roles and Responsibility Develop and implement regulatory strategies to achieve business objectives. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Analyze and interpret complex regulations to identify opportunities and challenges. Prepare and submit regulatory documents to relevant authorities. Monitor and report on regulatory changes that may impact the organization. Provide training and guidance to staff on regul...

Key Responsibilities JOB DESCRIPTION Your Responsibilities Include, But Are Not Limited To Prepare Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market. Draft Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market. Draft controlled correspondences on complex issues. Draft Deficiency responses for Complex Products and 505(b)(2) Products. Review API and FP in-vitro characterization/sameness reports. DMF review for complex APIs as per the workflow. To collaborate and work closely with cross functional teams. Qualifications M...

• Performing of Accounting for Payable , Receivable ,Bank etc. • Bank ,Vendor and Customer Reconciliation and Inventory Mgt. • Preparation of Financial Statement in compliance of IND AS and coordination with Statutory Auditors. • Build up strong Internal controls and ensure implementation as well as adherence. • Handling of Audits by external auditors. • Statutory dues working and payment within timeline. • Sound understanding of GST and Direct tax compliance like TDS , Advance Tax , GST etc • Preparation of MIS Data . • Knowledge for Capitalisation of Assets and verification Minimum Qualification: CA Inter Qualified SKILLS: Accounting & Computer Skills (Word, Excel, Powerpoint, ERP like Tal...

Job Title: Manager II – India Regulatory and business Conitnuity Business Unit: R&D1 Regulatory Affairs Job Grade G11A 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.” Key Responsibilities: To evalua...

We are looking for a highly skilled and experienced Regulatory Executive to join our team at Alvita Pharma. The ideal candidate will have a strong background in regulatory affairs and excellent communication skills. Roles and Responsibility Develop and implement regulatory strategies to achieve business objectives. Prepare and review regulatory documents, including applications and reports. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Conduct research and analysis on changing regulatory environments and their impact on the company. Build and maintain relationships with regulatory authorities and other stakeholders. Ensure timely submission of reg...

Job Title: Senior Executive / Manager 2 – Plant Regulatory Affairs Business Unit: R&D1 Regulatory Affairs Job Grade G11B/G11A Location Halol 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: Particip...

Role Overview: As a Regulatory Affairs Manager, your main responsibility will involve monitoring the company's production activities to ensure compliance with relevant regulations and standard operating procedures. You will be tasked with devising strategies for regulation compliance, organizing training programs to educate staff on policies and standards, conducting internal inspections and awareness campaigns, and staying updated on the latest rules and regulations in the industry. Key Responsibilities: - Demonstrate expertise in CMC aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents in adherence to ...

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...

JOB DESCRIPTION Title: Product Development Scientist - VMS (Vitamins, Mineral Supplements) Suggested Grade: Individual contributor role Minimum Qualification & Experience: Food Technology/Dairy Technology/Oils and Fats Technology with 5 – 10 yrs of experience in nutritional product development Preferred additional experience in VMS and other formats like bakery, Gummies,healthy Bar, Diskettes and Chocolate development & breakfast formats. Other requirements – familiar with manufacturing operations like spray drying, dry mixing, encapsulation techniques, liquids & beverages, etc Critical Skills Required : Knowledge of FSSAI standards, BIS norms, food laws and regulations in India Knowledge of...

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: 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: 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 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 : Document Management Systems (DMS) 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 project milestones are met, facilitating discussions to address challenges, and guiding your team through the development process...