Manager - 1

2 days ago

Tandalja, India SUN PHARMA Full time

Job Description: Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel. Prepare responses to deficiency letters received from various agencies. Maintain life-cycle / post approval changes for drug product registration dossiers. Provide regulatory support to cross functional departments. Prepare and submit scientific advice to various health authorities. eCTD compilation, verification and submission through electronic gateway Review, preparation and submission of annual reports to US FDA Review, preparation and submission of post approval supplements to US FDA Reviewing of the plant change control and established the variation strategy for submission Review of query response prepared and compiled by regulatory associates Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management Allocation of projects to regulatory associate & manage the team for all the regulatory submission activities

  • Senior Manager

    2 days ago

    Tandalja, India SUN PHARMA Full time

    1. Characterization of RLD pack samples. 2. Finalization of packing configuration for Exhibit batch packing of new generic product/NDA as per requirement. 3. Identification of new packaging material & new vendor development for packaging materials. 4. Mold development for primary packaging material & secondary packaging material & its validation. 5. Support...

  • SENIOR MANAGER

    2 days ago

    Tandalja, India SUN PHARMA Full time

    ·Designing, executing and interpreting bioassays/pharmacological studies. Knowledge of GLP/GMP. ·Leading and managing in-vitro/in-vivo projects, ensuring timely completion ·Mentoring junior scientists, building and leading cross functional teams ·Analyzing data, preparing reports and presenting to stakeholders · Collaborating with other departments, to...

  • Manager - 1 Packaging & Devices Development

    2 days ago

    Tandalja, India SUN PHARMA Full time

    Job Title: Senior Manager – Packaging Development Business Unit: R&D1 Regulatory Affairs Job Grade G9B/G9A Location : Baroda

  • General Manager

    2 days ago

    Tandalja, India SUN PHARMA Full time

    Job Title: Group Lead – FRD Non-Orals Job Grade: G7 Function: Formulation R&D Sub-function: FRD – Non-Orals Manager’s Job Title: Vice President- FRD Non-Orals Skip Level Manager’s Title: Function Head Title: Vice President- FRD Non-Orals Location: R&D Vadodara No. of Direct Reports (if any) 6 Date of Joining: Job Summary Group Lead – FRD Non-Orals...

  • Manager -2 MSTG

    2 days ago

    Tandalja, India SUN PHARMA Full time

    Job Title: Manager 2 – MSTG Non Orals 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...

  • Manager 2 - Regulatory & Business Continuity

    2 days ago

    Tandalja, India SUN PHARMA Full time

    Job Title: Manager – Regulatory & Business Continuity 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...

  • Executive - Regulatory Affairs

    2 days ago

    Tandalja, India SUN PHARMA Full time

    Job Title: Executive – Regulatory Affairs Business Unit: R&D1 Regulatory Affairs Job Grade G12A 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...

  • Executive - Regulatory & Business Continuity

    2 days ago

    Tandalja, India SUN PHARMA Full time

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

  • Executive - RA

    2 days ago

    Tandalja, India SUN PHARMA Full time

    Job Title: Executive – Regulatory and Business Continuity Business Unit: R&D1 Regulatory Affairs Job Grade G12A 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...

  • Manager-2

    6 days ago

    Tandalja, Vadodara, Gujarat, India Sun Pharmaceutical Industries Ltd Full time

    **Job description [Pharmacokinetic Scientist - 5 -7 years]- 1 position** - Literature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products towards different regulatory submission. - Review of BA/BE study protocol and provide Pharmacokinetic (PK) inputs into the study protocols - Developing protocol for patient...