What are the responsibilities and job description for the Senior Director Regulatory Affairs (Somerset, NJ) position at CEDENT?
The Role
Client 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 Client’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:
Client 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 Client’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 the 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, and 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 Client products.
- Build strong relationships with key external stakeholders including regulatory agencies, professional societies, and key opinion leaders, as relevant.
- 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 in 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.
