Senior Director, Regulatory Affairs -Specialty

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 :

Lupin vision was to grow a specialty brand business that launches innovative new products to address unmet medical needs.

Since its founding, Lupin’s U.S. brand business has been driven by that vision. We have marketed a range of products across therapeutic categories, including ANTARA® (fenofibrate) and METHERGINE® (methylergonovine maleate), as well as launching Inspira Chamber® (valved holding chamber), Brovana Inhalation Solution and Xopenex HFA.

While these brands treat a wide range of medical conditions, they have one important commonality : they are part of a sincere effort to broaden the treatment landscape for the benefit of patients and providers alike.

Our search for cutting-edge medicines to improve the treatment of special conditions and populations is never over. We are building our specialty business in therapeutic areas where we have synergy, including respiratory and neurological diseases.

The Role

Lupin is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.

In this role, you will be primarily responsible for the development of US / Global regulatory strategies to advance Lupin’s portfolio of development pipeline candidate drugs.

You will provide strategic input and ensure operational execution of global and US submission activities. You will be responsible for interfacing directly with the US FDA as the primary contact for the company for assigned programs.

This position is based in our Somerset, NJ office which requires onsite presence 50% of the time per our hybrid policy. This position will report to the SVP, RA (Generics, Biosimilar and Specialty).

Responsibilities :

The key responsibilities of this role will include, but are not limited to :

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 Genmab products.

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

Qualifications : Requirements :

Requirements :

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.

A broad knowledge of life-cycle management is highly preferred.

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.

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.

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