Senior Executive, Regulatory Affairs (US Injectable-Pre Approval)

Job Description

• Compile, prepare, review and submit ANDA submissions and Amendments to FDA with an overall objective to avoid major deficiencies and contribute to get 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 Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage form ANDAs either with Aseptic sterilization or Terminal sterilization or both techniques.
• Ensure timely submission of all assigned projects.
• Review / prepare documents which meet the requirement set forth by US FDA and accepted for review by FDA without query or RTR.
• Evaluate change controls and formulates strategies for correct filing categories, with minimal involvement of supervisor. Proactively raises major issues if any to superior for resolution and agreement. Compile and submits critical post-approval supplements, such as CBE, CBE-30 and PAS.
• 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 as well as Pre-submission meeting package (Pre-ANDA, Pre-IND and Pre-NDA) 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 available for t-cons 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

• 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.
• 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.
  
  

Required Skills

• Regulatory Submission & Dossier Filing | Advanced
• Regulatory Guidelines Knowledge | Advanced
• Cross Functional Communication | Intermediate
• Change Management & Documentation | Intermediate
• Problem Solving & Risk Mitigation | Intermediate
• Change Control & Regulatory Impact Assessment | Advanced
• Product Lifecycle Management | Advanced
• CMC Documentation | Advanced
• Health Authority Query Response | Advanced
• Regulatory Strategy Development | Advanced
  
  

Qualifications

M. Pharm

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

About The Team

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.