What are the responsibilities and job description for the Regulatory Affairs position at BuzzClan?
Position: Manager Regulatory Affairs
Location: Somerset, NJ (Hybrid)
Duration: Full time
Must have: CMC, CMC Labeling and ANDA, INDs
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)
