Job Information
Genmab Senior Director, Regulatory Affairs Strategy in Princeton, New Jersey
At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The Role
Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
In this role, the regulatory leader will be primarily responsible for the development of US regulatory strategies and have the role of Global Regulatory Strategist to advance Genmab's portfolio of development and marketed drugs. This individual will provide strategic input and ensure operational execution of US submission activities and work collaboratively with Regional Regulatory Strategists with responsibilities exUS. The individual will interface directly with the US FDA as the primary contact for assigned programs. Importantly, the chosen candidate will manage and mentor a group of Regulatory Affairs strategists.
As a key member of the Regulatory Affairs leadership team, you will play a critical role in ensuring compliance with global regulations and driving the growth of our company. The ideal candidate will have a strong background in regulatory affairs, exceptional leadership skills, and a passion for making a difference in the lives of patients. This position is based in our Princeton, NJ office with onsite presence 60% of the time and reports to the Head of Regulatory Affairs.
Responsibilities:
Key responsibilities include but are not limited to:
Act as the US/Global Regulatory Leader (GRL) for assigned project(s) and be responsible for the development, implementation, and maintenance of US/global regulatory strategies across all stages of development.
Lead, manage and mentor a team of regulatory professionals to ensure timely and successful submissions of drug applications to global regulatory agencies.
Evaluate regulatory risk and recommend mitigation strategies to ensure optimal regulatory success.
Provide expertise and guidance on global regulatory requirements, guidelines, and changes that may impact the company's products.
Prepare and review regulatory submissions, including INDs, (s)BLAs for accuracy, completeness, and compliance with regulations and guidelines.
Evaluate various regulatory mechanisms to optimize product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, compassionate use, pediatric plans, diversity action plans) and ensure that they are implemented, if applicable.
Consult with senior management to develop and communicate regulatory strategies and recommendations for products and programs.
Interact with US FDA for assigned projects. The US/GRL will lead and/or participate in meetings with FDA and other health authorities as appropriate.
Provide expertise and guidance on regulatory requirements, guidelines, and changes that may impact the company's products.
Build strong relationships with key external stakeholders including regulatory agencies, professional societies, and key opinion leaders.
Participate in review of and comment on regulatory guidance as relevant.
Drive continuous improvement initiatives to enhance regulatory processes, systems, and capabilities.
Requirements:
BSc or MSc level degree preferably within the life sciences (PharmD, PhD, or MD preferred)
Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred)
Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA)
A broad knowledge of development and life-cycle management is preferred.
Strong strategic skills including the ability to make complex decisions and willingness to support difficult positions
Solid knowledge and understanding of global and US regulations and the US pharmaceutical commercial landscape
Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
Direct hands-on experience with preparation and submissions of IND, (s)NDA/BLA to US FDA
Experience with labeling and PMC/PMR negotiations with US FDA
Ability to work well within cross-functional teams
Strong communication skills - both oral and written
Ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
Ability to influence others and resolve conflicts
Cultural awareness and respect for diversity
Unquestionable ethics, professional integrity, and personal values consistent with the Genmab values
For US based candidates, the proposed salary band for this position is as follows:
$206,250.00---$343,750.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.
About You
You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
You are a generous collaborator who can work in teams with diverse backgrounds
You are determined to do and be your best and take pride in enabling the best work of others on the team
You are not afraid to grapple with the unknown and be innovative
You...
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity