Senior Officer

5 days ago


maharashtra, India USV Full time

Position SummaryWe are seeking a Senior Officer- Regulatory affairs (Emerging Markets ) to join our team, he will be reporting to General Manager in this role, you will be responsible for Dossier compilation, preparation, Life cycle management, Pre approval, Post approvalJob Responsibilities:Collate/prepare and file dossiers in a timely and accurate manner for Formulations and API products to get licenses from various targeted markets (Emerging Markets/ROW).Review and regulatory impact analysis of the change control, communication with customer for notification and approval as applicable.Review and regulatory impact analysis of the changes notified by the vendors as per current regulatory requirements (country specific), as desired.Evaluate any changes proposed post-approval. Prepare and file necessary amendments / supplements / annual reports as applicable to ensure regulatory compliance (Post-approval Life Cycle Management).Prepare the checklist for documentation for regulatory fillings as per current regulatory requirements (country specific).Collate and conduct first-level review/overview of relevant standard technical documentation like stability, TTD, PDR, method validations etc. as per the country requirements.Conduct initial review of the specifications of the API / Semi-Finished Product / Finished Product as per the regulatory requirements.Conduct initial review of labelling/artwork as per the market where the dossier is being filed (only formulations).e-CTD compilation/ publishing of DMF / Dossiers and Submission to customer / Health Authorities.Assist in resolution of queries received from customer/agency/regulator and assessing them before sharing with team leader.Sharing copies of all Agency submissions pertaining to API and Approval package for FDF, with respective manufacturing sites.Submission of Renewals, Re-registrations, Tender (Emerging Markets).Proficiencies and Expertise●M.Pharm Only● Proven experience in Regulatory affairs with minimum 2.5 years.


  • Sales Officer

    2 days ago


    Mumbai, Maharashtra, India senior agency Full time

    Senior Agency Address: 413/C, Kalbadevi Rd, Marine Lines East, Wagh wadi, Kalbadevi, Mumbai, Maharashtra 400002 Urgent opening for the position of sales Officer (01) Education - graduation experience - upto 3 yrs **Salary**: 20k to 30k (As per Interview) Contact: 9821012193 Pay: ₹20,000.00 - ₹30,000.00 per month Schedule: - Day...

  • Office Boy

    4 days ago


    Kiwale, Pune, Maharashtra, India Avana Senior Care Full time

    **Job Summary**: The office boy plays a crucial role in supporting the daily operations of the elderly care facility by performing routine tasks, ensuring cleanliness, assisting staff, and handling errands. This role ensures a well-maintained, organized, and functional work environment for residents, staff, and visitors. **Requirements**: General Office...

  • Office Staff

    2 days ago


    Sanpada, Navi Mumbai, Maharashtra, India JAIPURIAR SENIOR SECONDARY SCHOOL, SANPADA Full time

    **Key Responsibilities**: - Perform general **admin and clerical tasks**: - **Scan and organize documents** accurately - Maintain digital and physical records - Assist in day-to-day **office operations**: - Manage incoming and outgoing files - Support the admin team in data entry and file maintenance **Skills Required**: - Basic computer knowledge (MS...

  • Senior Officer

    20 hours ago


    India, Maharashtra, Nerul USV Full time ₹ 4,00,000 - ₹ 6,00,000 per year

    Production - Senior Officer  -Fermentation upstream opertor. Should have experience in  Aseptic practices, Handling of Fermenter, Process vessels, Homogenizer, TFF systems, Filtration, Biosafety cabinet. Microbial fermentation experience. Manufacturing activities according to effective SOPs.Batch related documents in manufacturing area.Readiness related...

  • Senior Officer

    4 days ago


    India, Maharashtra, Govandi USV Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Position SummaryWe are seeking a Senior Officer- Regulatory affairs (Emerging Markets ) to join our team, he will be reporting to General Manager in this role, you will be responsible for Dossier compilation, preparation, Life cycle management, Pre approval, Post approvalJob Responsibilities:Collate/prepare and file dossiers in a timely and accurate manner...


  • Sanpada, Navi Mumbai, Maharashtra, India JAIPURIAR SENIOR SECONDARY SCHOOL, SANPADA, NAVI MUMBAI Full time

    English should be fluent. Can join immediately Should be well versed with MS Excel/MS Word **Job Type**: Permanent Pay: Up to ₹20,000.00 per month **Education**: - Bachelor's (preferred) **Experience**: - FRONT OFFICE & MARKETING: 2 years (preferred) - total work: 1 year (preferred) - FRONT OFFICE: 2 years (preferred) **Language**: - English...


  • Mumbai, Maharashtra, India Sun Pharmaceutical Industries Full time

    Job Title Senior Officer Executive Engineering Projects Business Unit Sun Global Operations Location Mumbai 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...

  • Office Boy

    1 week ago


    Andheri West, Mumbai, Maharashtra, India Exhicon Group Full time

    **Job Details for Office Boy Role**: - The office boy will be responsible for.... - Housekeeping work like dusting, cleaning, dry and wet mopping, etc. - Preparing and serving tea to staff and senior management - Washing utensils - filing the documents as and when asked by seniors - Opening and closing of the office - Any outdoor work as and when asked by...


  • Goregaon East, Mumbai, Maharashtra, India Global Sea Services Full time ₹ 4,20,000 per year

    Job Opening: Back Office Operations ExecutiveWe are looking for a smart, motivated, and detail-oriented individual to join our team as a Back Office Operations Executive at Mid-Senior positions.Location: Goregaon East, MumbaiEmployment Type: Full-timeExperience: 4 to 5 yearsQualification: Graduate from any streamKey Responsibilities:Manage day-to-day...

  • Office Assistant

    7 days ago


    Mumbai, Maharashtra, India RAM Graphics Full time

    This job is for office assistant who will be working with senior team and assisting them in making challans, invoices, delivery reports and other communication as required by seniors. Should have knowledge of Microsoft excel. **Salary**: ₹12,000.00 - ₹15,000.00 per month Supplemental pay types: - Commission pay - Yearly bonus **Education**: - Higher...