Project Management, Regulatory Affairs Jobs at Amneal Pharmaceuticals

Amneal Pharmaceuticals, Inc is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. Together, our team is working to build one of the most dynamic pharmaceutical companies in our rapidly changing industry. Today’s healthcare environment requires a new approach and new ideas.

Regulatory Affairs - MDI/DPI resource at Corporate Office Ahmedabad for Inhalation dosage form.
Post : 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

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.