Amneal Pharma - Multiple Requirements in Project Management / Regulatory Affairs - Apply Now - PHARMA WISDOM

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Wednesday, 9 September 2020

Amneal Pharma - Multiple Requirements in Project Management / Regulatory Affairs - Apply Now


Urgent Requirement - Manager / Sr. Manager in RA for Inhalation Dosage


We have requirements in Regulatory Affairs - MDI/DPI resource at Corporate Office Ahmedabad for Inhalation dosage form.

Position: Manager / Sr. Manager

Experience: 8-13 yrs

Primary Functions:

  • Compile, prepare, critically review and submit the US ANDAs and EU applications for Inhalation dosage form with high-quality, following the regulatory guidelines and internal processes within time lines.
  • Ensure timely submission of all assigned projects.
  • Ensure final US ANDA and EU applications meets the requirement of latest ANDA checklist recommended by USFDA and EU authorities to avoid any acceptance to file issue.
  • Prepare regulatory strategies for all assigned projects covering all key points.
  • Work very closely with US regulatory Project manager at the time of product initiations, R&D phase, ANDA/Bio Execution and after initiation of stability to ensure timely availability of all documents to ensure timely submissions.
  • Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.
  • Submit controlled correspondence to FDA on specific issues as needed for assigned projects.
  • Proactively raises major project issues to superior for resolution and agreement.
  • Evaluate final compositions for IIG and Proportionality similar criterias and develop regulatory strategies to avoid acceptable for filing issues.
  • Review the DMFs thoroughly and share the review comments to purchase department on-time. Follow up with purchase team or with DMF holder directly as needed to ensure compliance to provided comments on-time.
  • Proofread and approve labeling for assigned products.
  • Ensure that labeling complies with all federal, state and local requirements/regulations and component format conforms to specifications to assure optimal functionality.
  • Coordinates with external vendors for project support activities.
  • Track the committed timeliness and follow up with the internal departments proactively for required documents.

Secondary Functions:

  • Communicate with consultants, attorneys and external parties as needed to obtain scientific data for submissions.
  • Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department.
  • Maintain current knowledge of regulations and other issues that affect products and industry

Urgent Requirement - Project Management Department

We have multiple requirements in Project Management at our R&D centre Ahmedabad for Injectable & OSD dosage form.

Position: Sr. Exe to AGM

Experience: 8-13 yrs

Job Responsibilities:

  • This position will build an accomplished PM program by developing and designing efficient and innovative systems to provide unique solutions and support to the various functional heads and executive management.
  • Must possess skills to be a strong people manager with ability to develop and groom internal talent and have a solid understanding of the various aspects of the generic business.
  • Lead and manage all activities related to product development through the entire product cycle from strategic and tactical perspectives and with internal and external stakeholders. Be a thought leader to anticipate issues and propose creative solution on a functional basis.
  • Continue to proactively build new PM systems to meet evolving business needs.
  • Possess a deep understanding of the technical details underlying product development to effectively strategize, plan and co-ordinate project activities with the functional stakeholders and senior management.
  • Ability to lay specific emphasis on complex programs and projects across dosage forms and significantly contribute to the technical and other strategic perspectives as part of decision making.
  • Lead PM as an independent function to effectively manage budgets, communicate project expectations and timelines, proactively anticipate project related issues and devise contingency plans.
  • Build strong relationships with cross-functional and multi-disciplinary stakeholders to drive various project requirements in an efficient manner.
  • Must have the capability to build strong team dynamics of diverse individuals representing the various functions as part of product development.
  • Must have the ability to work with external vendors such as CROs, CMOs, consultants, material vendors and other external third parties to drive a strong development program for the US markets.


  • Must be a high energy, assertive and detail oriented individual with a strong technical background and deep understanding of product development.
  • A well-developed understanding of the generic pharmaceutical development process acquired through a minimum of 5 years of industry experience in preferably one of the following areas: drug formulation / analytical development, clinical strategy development or project management.
  • Prior experience in Product development is an absolute requirement for this position. Understanding of multiple functional areas and exposure to complex dosage form development is required.
  • A thorough understanding of the Regulatory process and Intellectual Property issues as it pertains to ANDA filings is necessary.
  • A proven ability to manage teams and possess strong interpersonal, oral and written communication skills.

Please share your CV at along with Current & Expected CTC.


Puja Sinha

Amneal Pharma

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