Roles and Responsibilities:

• Analyze requirements specified by FDA pertaining to REMS and other patient safety programs
• Works closely with Pharmacovigilance, Commercial Operations, Finance and Legal in the development and management of REMS Programs
• Review and approve REMS program deliverables
• Monitor and report progress of the program launches and operations, identify risks, highlight issues, seek input/approval from the management
• Participate and/or lead the evaluation & selection of REMS vendors according to Lupin’s procurement policies where applicable
• Review ANDAs, supplements, amendments and highlight any major gaps in the submission documents
• Independently manage some of the business development product applications (Prepare CMC/labeling documents for registration submissions, such as ANDAs, INDs, NDAs Amendments, Supplements and Annual Reports)
• Conducting trend analysis of received deficiencies
• Provide CMC strategy and raise key issues throughout the lifecycle of products in a timely manner to project teams and management.
• Independently review, compile and submit high‐quality controlled correspondences and meeting requests
• Works closely with the licensing vendor in the management of all product distribution licenses for all Lupin USA commercial entities and highlight any major gaps/change of regulation that may impact the commercial operations
• Responsible for maintaining and updating various regulatory databases to ensure accuracy of information
• Any additional responsibilities as assigned by hiring manager

Job‐specific Competencies/Skills

• A deep appreciation of FDA REMS program requirements and key processes
• Knowledge on current FDA regulations and guidance regarding REMS, including Medication Guides, ETASU, Shared REMS, Survey Methodologies, etc.
• Prior experience of participating in designing and implementing REMS systems
• Exhibit strong knowledge on CMC and Labeling aspects of regulatory submissions
• Knowledge and understanding of pharmaceutical product development and regulatory requirements for product development and approval for USA region as well as life cycle management of products.
• Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
• Good understanding and knowledge on US FDA and ICH guidance
• Able to successfully interpret and apply regulatory intelligence to work output.
• Hands on experience on eCTD publishing tool and Proficient in pertinent software and tools.
• Experience working in a complex and matrix environment.
• Experience in working with cross‐functional teams and with multiple stakeholders.
• Demonstrates acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Excellent verbal and written communication skills.
• Demonstrated ability to learn & process new information quickly
• Attention to detail and quality
• High degree of demonstrated proficiency with Excel, Word and PowerPoint
• Advanced computer skills & ability to conduct research through the internet
• Good interpersonal skills and ability to work with diversified teams

Qualifications And Education Requirements

• Bachelor or Master’s Degree in a scientific area (Degree in Pharmacy/Regulatory Affairs is preferred)
• 6‐8 years’ experience in the pharmaceutical industry with 3‐5 of those years in regulatory affairs preferred
• Prior experience of participating in managing, designing and implementing REMS systems (highly advantageous)