Manager 2- Formulation Development Non Orals

4 days ago

India Sun Pharmaceutical Industries - Full time ₹ 12,00,000 - ₹ 36,00,000 per year


Job Title:



Manager-2 - FR&D Non-Orals (Compliance group)  



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."

Job Description

  • Review documents required for regulatory submissions across global markets, including product development reports and scientific justifications for responding to regulatory queries.
  • Evaluate and review documents related to technology transfer to ensure accuracy and regulatory compliance.
  • Review protocols and reports for various product development studies of Non-Oral products to ensure scientific soundness and regulatory alignment.
  • Review documents required for drug-device combination products in accordance with applicable regulatory requirements.
  • Review filter validation reports and conduct risk assessments for extractables and leachables, elemental impurities, and nitrosamine impurities.
  • Prepare and review Standard Operating Procedures (SOPs) and internal guidelines to ensure system compliance.
  • Review investigation reports related to failures, Out of Specification (OOS), and Out of Trend (OOT) results, and support root cause analysis.
  • Ensure adherence to internal quality systems and regulatory standards & conduct SOP training.


Travel Estimate



NA



Job Requirements



Educational Qualification



M Pharm



Experience



Tenure: 9-11 years



Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together

 



Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).


  • General Manager

    1 week ago

    Vadodara, India SUN PHARMA Full time

    Job Description 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 Areas...

  • Executive - FRD Non-Orals

    4 days ago

    India Sun Pharmaceutical Industries - Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Title:Senior Executive / Executive – FRD Non-Orals Business Unit:R&D1 Regulatory AffairsJob GradeG11B / G12ALocation:BarodaAt 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 - FRD Non Orals

    4 days ago

    India Sun Pharmaceutical Industries - Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Title:Executive – FRD Non Orals Business Unit:R&D1 Regulatory AffairsJob GradeG12ALocation:BarodaAt 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...

  • Executive FRD Non Orals

    4 days ago

    India Sun Pharmaceutical Industries - Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Title:Executive – FRD Non Orals  Business Unit:R&D1 Regulatory AffairsJob GradeG12ALocationBarodaAt 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...

  • Executive - Formulation Development (Orals)

    2 days ago

    India Sun Pharmaceutical Industries - Full time ₹ 5,00,000 - ₹ 25,00,000 per year

    Literature search, product understanding, data interpretation for product to be undertaken for development.Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader.Planning and execution of product development work to achieve desired product profile and data compilationScheduling the work plan in...

  • ▷ [3 Days Left] Formulation R&D (Sr Manager/AGM)

    1 week ago

    Bengaluru, India RESONACLE Full time

    Job Description We are seeking a highly skilled Formulation R&D professional to lead the development of oral drug delivery systems, primarily focusing on soft gelatin capsules, tablets, and sachets. The role involves driving end-to-end formulation development, process optimization, and technology transfer from lab to commercial scale. The incumbent will be...

  • ▷ Urgent! Formulation R&D

    5 days ago

    Hyderabad, India Promea Therapeutics Full time

    Job Description Job Responsibilities - Formulation Design & Development - Design and develop robust, scalable formulations for oral solid dosage forms (OSDs) including tablets, capsules, and granules. - Select appropriate excipients, processing techniques (e.g., direct compression, wet/dry granulation), and equipment. - Develop formulations that meet target...

  • Manager -2 MSTG

    4 weeks ago

    Vadodara, India SUN PHARMA Full time

    Job Description 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 MSTG

    4 days ago

    India Sun Pharmaceutical Industries - Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Title:Manager 2 – MSTG Non OralsBusiness Unit:R&D1 Regulatory AffairsJob GradeG11ALocation :BarodaAt 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...

  • General Manager

    4 days ago

    India Sun Pharmaceutical Industries - Full time ₹ 10,00,000 - ₹ 30,00,000 per year

    Job Title:Group Lead – FRD Non-OralsJob Grade:G7Function:Formulation R&DSub-function:FRD – Non-Orals Manager's Job Title:Vice President- FRD Non-OralsSkip Level Manager's Title:Function Head Title:Vice President- FRD Non-OralsLocation:R&D VadodaraNo. of Direct Reports (if any)6Date of Joining:Job SummaryGroup Lead – FRD Non-OralsAreas of...