Senior Executive, Regulatory Affairs

Growth For Impact; Ahmedabad District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Growth For Impact in India seeks a Regulatory Affairs specialist to compile, review, and submit IND, NDA, and ANDA filings to FDA, with a focus on CMC strategies and timely approvals.

The role requires strong communication, meticulous documentation, and the ability to coordinate with US teams and global health authorities, ensuring compliance with ICH, FDA, and 21 CFR.

Qualifications

• Experience with ANDAs, INDs, NDAs and FDA correspondences.
• Strong written and verbal communication.
• Time management, organization and multitasking in a fast-paced environment.
• Ability to interface with professionals domestically and abroad.
• Working knowledge of ICH, FDA and 21 CFR regulations.
• Should archive and maintain all submissions in a systematic way.

Responsibilities

• Compile, prepare, review and submit IND, NDA and ANDA submissions to FDA.
• Develop and implement CMC regulatory strategies for IND/NDA and ANDA submissions.
• Maintains full awareness of regulatory activities and ensures deadlines are met.
• Ensure high quality, compliant submissions aligned with cGMP, ICH, FDA expectations.
• Prepare and finalize pre-submission packages for FDA or EU as needed.
• Ensure timely submission of all assigned projects.
• Assess deficiency letters and develop response strategies.
• Review API DMFs and coordinate with DMF holders for comments.
• Work flexibly to accommodate US team schedule.

Skills

Regulatory strategy

IND/NDAs/ANDAs

FDA communications

Project management

Attention to detail

Cross-functional collaboration

Communication skills

Education

B.Pharm/M.Pharm

Tools

MS Word

Excel

PowerPoint

Outlook

Adobe Acrobat

Job description

ROLE

• 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.
• Prepare and finalize controlled correspondence as well as Pre-submission meeting package to FDA or EU on specific issues as needed for assigned projects.
• Ensure timely submission of all 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.
• Evaluate post-approval change controls and formulates strategies for correct filing categories.
• 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.

REQUIREMENTS

• Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects.
• Excellent written 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.
• 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.
• B. Pharma / M. Pharma – Required
• Must have 5-9 years of Regulatory Affairs CMC, handling Complex Product.