- 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. Requirements
- 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 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 Locations
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Director, Regulatory Advertising
3 days ago
Genmab Princeton, United States Full timeAt 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, ca ...
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Director, Regulatory Advertising
1 week ago
Genmab Yardley, United StatesAt 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, ca ...
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Director, Regulatory Advertising
1 week ago
Genmab Helmetta, United StatesAt Genmab, were 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, can ...
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Sanofi Group Bridgewater, United States**Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs** · + Location: Cambridge, MA or Bridgewater, NJ · **About the job** · The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC ...
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Sanofi EU Bedminster, United StatesJob title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs · Location: Cambridge, MA or Bridgewater, NJ · About the job · The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC Regula ...
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Associate Director
1 week ago
Novo Nordisk A/S Princeton, United StatesAbout the Department · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to ...
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Account Executive
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Director, Worldwide Media and Planning
2 days ago
Bristol Myers Squibb Princeton, United States Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
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Otsuka Princeton, United States Full timeDescription · The Head of Strategic Sourcing leads a team of ~12 individuals focused on driving an efficient and effective Sourcing process. Responsibilities include the following areas: · Overall Responsibility Strategic Sourcing area · Partners with the ELT to create a Sourci ...
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Associate Director
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Associate Director
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BioSpace, Inc. Princeton, United StatesAbout · About the Department · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the ...
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Cco
4 weeks ago
Genmab Princeton, NJ, United StatesAt 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, ca ...
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associate ii regulatory labeling
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TK-CHAIN LLC Princeton, United StatesJob Description · Job DescriptionSUMMARY OF POSITION · The Associate, Regulatory Labeling prepares, reviews and submits to his/her manager high-quality regulatory labeling submissions intended for the FDA within company timelines and in accordance with regulatory guidelines and a ...
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associate ii regulatory labeling
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Senior Regulatory Affairs
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Diverse Lynx Princeton, United StatesHi, · Welcome to Diverse Lynx We combine industry leading expertise and our personal dedication to help you find your next career opportunity. We are a Minority and Women Owned Business Enterprise (MWBE) certified by the State of New Jersey and Minority Business Enterprise (MBE) ...
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Senior Legal Counsel
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Director HCP Marketing, Rheumatology
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Director HCP Marketing, Rheumatology
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Director, Regulatory Advertising - Princeton, NJ, 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 * Provide regulatory leadership and direction to the cross-functional Medical, Regulatory and Legal (MeRL) Committee.$170, $284,375.00 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
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 GenmabGenmab 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 inclusionWe 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.
