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

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

Greetings!

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.

Requirements:

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 pujas@amnealindia.com along with Current & Expected CTC.

Regards,

Puja Sinha

Amneal Pharma

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