- Provide regulatory leadership and direction to the cross-functional Medical, Regulatory and Legal (MeRL) Committee.
- Ensure timely and accurate submission of promotional materials to the FDA.
- Monitor and assess the impact of new or changing regulations, guidances, and enforcement actions on promotional activities.
- Provide training and education to internal and external stakeholders on regulatory requirements and best practices for advertising and promotion.
- Establish and maintain effective relationships with regulatory agencies, alliance partners, and industry associations.
- Bachelor's degree in life sciences, pharmacy, or related field. Advanced degree preferred.
- Minimum of 10 years of experience in regulatory affairs, with at least 5 years in advertising and promotion compliance.
- Expert knowledge of US laws, regulations, and guidances related to pharmaceutical advertising and promotion. Familiarity with global regulations and standards is a plus.
- Strong leadership, communication, and interpersonal skills.
- Ability to work collaboratively and influence cross-functional teams.
- Ability to manage multiple projects and prioritize competing deadlines.
- Ability to think strategically and creatively to solve complex regulatory challenges.
- 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 have experience working in a fast-growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so
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Director, Regulatory Advertising - Princeton, United States - Genmab
Description
Job Description
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
The Director, Regulatory Advertising & Promotion is responsible for ensuring that all promotional materials and activities comply with the applicable laws, regulations, and guidelines in the US. You will be responsible for the review of promotional materials, providing strategic guidance to the commercial teams, and interacting with FDA's OPDP on advertising and promotion matters.
Responsibilities
Requirements
For US based candidates, the proposed salary band for this position is as follows:
$170, $284,375.00The 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
Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSOTM) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website
Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
