Job Description

Job Responsibility: Regulatory Affairs

Must have expertise/prior experience in Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage form ANDAs either with Aseptic sterilization or Terminal sterilization or both techniques.
Compile, prepare, review and submit IND, NDA and ANDA submissions along with associated Amendments to FDA with an overall objective to avoid major deficiencies and contribute to get approval within the shortest timeframes possible.
Develop and implement CMC regulatory strategies for IND/NDA and ANDA submissions, lifecycle management, and deficiency responses to ensure timely approvals.
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.
Ensure high quality, compliance-driven submissions aligned with cGMP, ICH, and FDA expectations. Drive first-cycle approval success, minimize deficiency rates, and ensure Right First Time submissions.
Prepare and finalize controlled correspondence as well as Pre-submission meeting package (Pre-ANDA, Pre-IND, Pre-NDA and EU scientific advisory meetings) to FDA on specific issues as needed for assigned projects.
Ensure timely submission of all assigned projects. Work very closely with all relevant departments at the time of product initiations, R&D phase, NDA/ANDA Execution and after initiation of stability to ensure availability of all documents to ensure timely submissions.
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.
Evaluate post-approval change controls and formulates strategies for correct filing categories, with minimal involvement of supervisor. Compile and submits critical post-approval supplements, such as CBE, CBE-30 and PAS.
Proactively raises major project issues to superior for resolution and agreement.
Be flexible in timings and available for teleconferences as per US team schedule.
Evaluate final compositions for IIG and Proportionality similar criteria's 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.

Responsibilities / Skills

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, NDAs and FDA correspondences.
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.
Aware of eCTD regulations and health authorities expectation.
Strong computer skills in order to learn new programs as quickly as possible. Experience in MS Word, Excel, Power-point, Outlook and Adobe Professional is a must.

Education

QUALIFICATIONS

B. Pharm B. Pharm - Required
M. Pharm M. Pharm - Preferred

Experience:

5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

Senior Executive, Regulatory Affairs