Sr. Director, Regulatory Affairs Specialty

Overview
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, Regulatory Affairs.

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

Design and implement robust regional and global regulatory strategies for assigned program/products.
Act as primary point of contact for assigned products, engaging with local regulatory authorities, including the U.S. FDA.
Lead submission preparation and oversight activities for INDs, and NDAs; liaise with other regions to coordinate major regulatory filings globally.
Lead and coordinate activities across all areas of regulatory such as CMC and labeling to ensure comprehensive and compliant regulatory filings throughout the lifecycle of the product(s).
Provide regulatory expert assessments of potential in-licensing/acquisition opportunities.
Evaluate regulatory risk and recommend mitigation strategies to the cross-functional teams and management.
Consult senior management to develop and communicate regulatory strategies and advice for products and programs.
Monitor the current regulatory environment/landscape by assessing regulatory guidelines, regulations, 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.
Qualifications
Qualifications for thie role are:

MSc level degree preferably within the life sciences (PharmD, PhD preferred)
Minimum of 5-8 years of direct industry experience within Regulatory Affairs; experience working on respiratory/inhalation or neurology products is highly desired.
Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA, MHRA, Health Canada)
Solid knowledge and understanding of US regulations and the US pharmaceutical market, with direct experience filing and managing NDA 505(b)(1) or (2) applications.
Experience with FDA facilitated regulatory pathways (i.e. Fast Track, breakthrough therapy designation) highly preferred.
Knowledge and direct experience working in both the pre-approval and post-approval product lifecycle.
Strong strategic skills include 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.
Highly motivated and self-driven individuals enjoy being challenged.
The anticipated salary range for this position in New Jersey is $220,000.00 - $255,000.00, plus discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states.

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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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.