Manager, Regulatory Affairs

Overview

Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of Fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.

Responsibilities

ROLE AND RESPONSIBILITIES:  

• Manage Lupin’s existing REMS programs and help in the development of new REMS programs (as needed) with the support of the supervisor
• 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 timelymanner 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

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)

Lupin  is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.

Physical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.

Search Firm Representatives Please Read Carefully 

Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails