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Lupin Pharmaceuticals · 4 days ago

Vice President, Global Regulatory Affairs, Strategy (Specialty Pharma)

Somerset, NJ

Full-time

Hybrid

Lead/Staff, Director/Executive

5+ years exp

Lupin Pharmaceuticals is a fast-growing and innovative company focused on generic and branded pharmaceuticals, particularly in women's health. They are seeking a Vice President of Global Regulatory Affairs to develop and implement regulatory strategies for their drug portfolio, ensuring compliance and successful submissions to the FDA. The role involves direct interaction with regulatory agencies and requires strong leadership in managing cross-functional teams.

BiotechnologyPharmaceuticalRobotics

H1B Sponsor Likely

Responsibilities

Act as the US Regulatory Leader for assigned project(s) and be responsible for the development, implementation, and maintenance of US/global regulatory strategies at various stages of development (in line with Product Development Plan)

Evaluate competitive landscape and various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, pediatric plans) and present options and recommendations to expedite the path to market, as applicable

As assigned by management, provide regulatory due diligence assessment of licensing/acquisition opportunities

Work closely with CFT to successfully meet project deliverables while adhering to regulatory requirements for programs and submissions

For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented including label improvement, health authority meetings. This responsibility may involve collaboration with a partner

Evaluate regulatory risk and recommend mitigation strategies to the cross-functional teams and management

Participate in the development and review of submission documentation to support successful INDs/CTAs as well as marketing applications

Consult with senior management to develop and communicate regulatory strategies and advice for products and programs

Monitor and assess regulatory guidelines, regulations, and current regulatory environment/landscape, and their impact on the development of Lupin products

Build strong relationships with key external stakeholders including regulatory agencies, professional societies, and key opinion leaders, as relevant

Qualification

Regulatory AffairsUS FDA interactionGlobal regulatory strategiesLife sciences degreeIndustry experienceRegulatory submissionsStrategic skillsOrganizational skillsCommunication skillsTime managementConflict resolutionSelf-motivated

Required

MSc level degree preferably within the life sciences (PharmD, PhD preferred)

Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Inhalation and Neurology and Other therapeutic areas)

Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA)

Solid knowledge and understanding of global and US regulations and the US pharmaceutical market, in 505(b)(1) and (2) application submissions and approvals

Strong strategic skills including the ability to make complex decisions

Strong organizational, communication (both oral and written), and time management skills needed to manage multiple ongoing projects/tasks simultaneously

Ability to influence others and resolve conflicts

Highly motivated and self-driven individual who enjoys being challenged

Preferred

A broad knowledge of life-cycle management is highly preferred

Company

Lupin Pharmaceuticals

Lupin Pharmaceuticals is a generic pharmaceutical company.

Founded in 2003

Baltimore, Maryland, USA

501-1000 employees

http://www.lupinpharmaceuticals.com

H1B Sponsorship

Lupin Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (3)

2024 (6)

2023 (2)

2022 (8)

2021 (6)

2020 (4)