Amneal Pharmaceutical jobs for Regulatory Affairs apply now 

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Amneal is looking for Regulatory Affair professionals, who have experience of USA market. Details are given below:


Designation:

Sr. Executive / Asst. Manager

Education:

B. Pharma / M. Pharma - Required

Experience:

Must have 3-5 years of Regulatory Affairs CMC, handling Topical, Transdermal, Liquid & Solid Oral and/or Nasal dosage forms.

Description:

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The Regulatory Affairs Executive CMC (Chemistry, Manufacturing & Controls), with minimal guidance prepares, reviews and submits high quality, regulatory submissions such as ANDAs/Amendments to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Having prior experience in handling Topical, Transdermal, Liquid & Solid Oral and/or Nasal dosage form in US market.

Essential Functions:
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Compile, prepare, critically review and submit ANDA submissions and Amendments to FDA with an overall objective to receive approval within the shortest timeframes possible. 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.
Must have expertise/prior experience in Topical/Semi-solid, Liquid-oral, Solid-oral, Nasal dosage form ANDAs.
Ensure timely submission of all assigned projects.
Ensure final ANDA meets the requirement set forth by USFDA and accepted for review by FDA without query or RTR.
Evaluate change controls and formulates strategies for correct filing categories, with guidance from supervisor. Proactively raises major project issues if any to superior for resolution and agreement. Compile and submits critical post-approval supplements, such as CBE, CBE-30 and PAS as and when necessary.
Work very closely with all relevant departments 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.
Prepare and finalize controlled correspondence to FDA on specific issues as needed for assigned projects.
Assess the deficiency letter immediately after receipt from FDA, perform in-detail gap assessment and discuss with superiors to finalize the strategy to respond the deficiency.
Proactively raises major project issues to superior for resolution and agreement.
Be flexible in timings and intermittently available for t-cons as per US team schedule.
Evaluate final compositions for IIG and Proportionality similar criteria and develop regulatory strategies to avoid acceptable for filing issues.
Review the API 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.
Proof-read and approve all OTC and Rx product labeling components.

Additional Responsibilities / Skills:
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Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects.
Excellent written (Technical writing) and verbal communication skills and interpersonal skills.
Prior experience working with ANDAs, INDs and NDAs.
Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required.
Ability to communicate effectively and collaboratively as part of a team in a respectful manner.
Ability to interface with professionals domestically and abroad.
Ability to work independently, self-starter.
Working knowledge of ICH, FDA and 21 CFR regulations.
Should archive and maintain all submissions in a systematic way.
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.
Good problem solving skills and analytical ability.
Strong computer skills in order to learn new programs as quickly as possible. Experience in MS Word, Excel, Power-point, Outlook and Adobe Acrobat is a must.

If the above requirements suits with you please share your CV at pujas@amnealindia.com


Regards,

Puja Sinha

HR

Amneal Pharma

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