Jobs
>
New York City

    Director, Regulatory Affairs, Advertising and Promotion - New York, United States - BioTalent

    BioTalent
    BioTalent New York, United States

    3 days ago

    Default job background
    Description
    Director, Regulatory Affairs, Advertising and Promotion (Ad/Promo)
    Remote

    – United States

    Seeking a Director of Regulatory Affairs for Advertising and Promotion to lead commercial regulatory strategy and leadership for the US business for a commercialized biopharmaceutical focused on Oncology.

    This new hire will ensure compliance in US marketing activities by reviewing promotional and non-promotional materials for regulatory adherence and compliance to ensure the Company's commercial efforts meet regulatory standards while driving business goals and objectives.

    Seeking a confident leader to advise on promotional regulatory impact for new campaigns and product labeling. You'd be overseeing the regulatory assessment and research on regulatory precedence to evaluate ad/promo issues for various products. Chair the MLR review committee, and serve as FDA (OPDP) liaison,

    ensuring timely submissions. The

    Director will advise cross-functional teams & stakeholders on commercial

    regulatory guidance for corporate communications.

    You'll have the opportunity to provide regulatory input to various functional units on promotional labeling for marketed and to-be-marketed drugs and serve as the lead regulatory affairs representative.


    Qualifications:
    BS/MS degree in a scientific discipline or equivalent

    experience is required (Advanced degree preferred).

    9 years in regulatory affairs within biopharmaceutical industry.

    5 years of direct experience in regulatory advertising and promotional material review is required.

    Direct experience with OPDP as a liaison.

    Extensive knowledge of US/EU submissions

    Strong working knowledge and experience with FDA regulations

    New product launch experience is highly preferred.

    Oncology promotion experience is required.

    Rare disease promotion experience is a plus.

    #J-18808-Ljbffr
  • Comcast Corporation

    Account Executive, Strategic Growth

    1 week ago

    Comcast Corporation New York, United States

    Comcast brings together the best in media and technology. We drive innovation to create the world's best entertainment and online experiences. As a Fortune 50 leader, we set the pace in a variety of innovative and fascinating businesses and create career opportunities across a wi ...

  • Amazon Services LLC

    Buyer/vendor Manager, Amazon Fresh

    2 days ago

    Amazon Services LLC New York, United States

    3+ years of with Excel experience · - 5+ years of retail, operations, product or program management, or business management/consulting with negotiations and delivering results experience · - Bachelor's degree, or 3+ years of professional or military experience · - Experience with ...

  • Google

    Community Relations and Marketing Lead

    4 hours ago

    Google New York, United States

    **Minimum qualifications**: · - Bachelor's degree or equivalent practical experience. · - 6 years of experience in management consulting, sales operations, business strategy, investment banking, venture capital, private equity or corporate advisory, or 4 years of experience with ...

  • William Barthman Jeweler, LTD

    Marketing/social Media Specialist

    1 week ago

    William Barthman Jeweler, LTD New York, United States

    Title: · Marketing & Social Media Specialist · Summary: · William Barthman Jeweler is a leading retailer of luxury watches and jewelry, and has been in business since 1884. The Company's Marketing & Social Media Specialist will be a key member of the Company and will support the ...

  • Comcast Corporation

    Marketplace Ad Operations Analyst

    1 week ago

    Comcast Corporation New York, United States

    FreeWheel, a Comcast company, provides comprehensive ad platforms for publishers, advertisers, and media buyers. Powered by premium video content, robust data, and advanced technology, we're making it easier for buyers and sellers to transact across all screens, data types, and s ...

  • Penguin Random House LLC

    Marketing Manager, Berkley

    4 hours ago

    Penguin Random House LLC New York, United States

    When you glance at your bookshelf, are all the spines B for Berkley? Have the past books you have read fall within one of these genres: a romance, a mystery/thriller, women's fiction, historical fiction, or sci-fi/fantasy? Are you ready to take your skills to the next level in pr ...

  • Univision communications inc

    Sales Coordinator

    4 hours ago

    Univision communications inc New York, United States

    ABOUT THE ROLE & TEAM: · The Sales Coordinator will be responsible for daily account maintenance in all aspects of the order process. The Sales Coordinator should manage their time well in the fast-paced environment exhibiting attention to detail. The Sales Coordinator should hav ...

  • Good Feet

    Head of Marketing

    5 days ago

    Good Feet New York, United States

    Job Summary · - Stretch*d was founded in 2018 as the premier brand in the one-on-one assisted stretching and recovery category, offering clients the most effective and feel-good way to "get loose." Through our two New York City locations (growing from two to more in 2024 and beyo ...

  • Florida Cardiopulmonary Center

    Marketing Coordinator

    4 days ago

    Florida Cardiopulmonary Center Orange City, United States

    **Marketing Coordinator Cardiovascular Practice**: · - Florida Cardiopulmonary Center (FCC)_is looking to add a star to its team We are looking for a proactive person that thrives in a fast-paced environment as part of a team managing day-to-day marketing tasks, coordinating pati ...

  • Shake Shack

    Marketing Manager, Global Licensing

    6 days ago

    Shake Shack New York, United States Full time

    We Stand For Something Good · Our secret to leading the way in hospitality? We put our people first · At Shake Shack, our mission is to Stand For Something Good in all that we do. You'll learn lifelong skills and be empowered to make a positive impact—on our business, restaurants ...

  • Comcast Corporation

    Account Director

    5 days ago

    Comcast Corporation New York, United States

    FreeWheel, a Comcast company, provides comprehensive ad platforms for publishers, advertisers, and media buyers. Powered by premium video content, robust data, and advanced technology, we're making it easier for buyers and sellers to transact across all screens, data types, and s ...

  • CJ

    Client Partnerships Associate

    1 day ago

    CJ New York, United States

    **Company Description** · From helping to invent the affiliate industry, to performance marketing and what comes next, we've earned a reputation for maintaining the largest, most reliable partnership-based platform and sterling service with a personal touch. Founded in Santa Barb ...

  • Equativ

    Customer Success Manager

    1 day ago

    Equativ New York, United States

    **Role Summary** · As a Customer Success Manager at Equativ, you will play a critical role in ensuring the success and satisfaction of both agency and self-service clients. Your primary focus will be to drive customer adoption and usage of our deal curation platform, monitor and ...

  • NowThis

    Nowmedia Integrated Marketing Manager

    1 week ago

    NowThis New York, United States

    New York, New York · - Work Type: Full Time · **Position**:Integrated Marketing Manager**Organization**: NowMedia Network**Department**:Marketing**Reports To**: Head of Brand and Creative Development**Location**: New York, NY (Hybrid/Remote flexibility)**About NowMedia Network** ...

  • American Association of Advertising Agencies, Inc

    Svp, Member Engagement

    5 days ago

    American Association of Advertising Agencies, Inc New York, United States

    **Position Overview** · The role of the SVP, Member Engagement & Development Eastern Region is to provide leadership, guidance and advocacy to 4A's membership leveraging 4A's resources and benefits. In addition, the role will be the primary new member development lead responsible ...

  • American Association of Advertising Agencies, Inc

    Manager, Business Intelligence

    1 day ago

    American Association of Advertising Agencies, Inc New York, United States

    **Position Overview** · **Position Responsibilities** · **Manage the end-to-end delivery of survey projects, including**: · - Lead the survey process by actively partnering with senior business leads to identify, size, scope and create timelines of survey projects for each fiscal ...

  • Comcast Corporation

    Account Manager

    1 week ago

    Comcast Corporation New York, United States

    FreeWheel, a Comcast company, provides comprehensive ad platforms for publishers, advertisers, and media buyers. Powered by premium video content, robust data, and advanced technology, we're making it easier for buyers and sellers to transact across all screens, data types, and s ...

  • Blue Note Jazz Club

    Marketing Manager

    6 days ago

    Blue Note Jazz Club New York, United States

    **OVERVIEW** · Blue Note Entertainment Group is seeking a highly motivated Marketing Manager with a music and entertainment background to directly support the Blue Note New York Marketing Director for the iconic Blue Note Jazz Club in New York City. · **RESPONSIBILITIES**: · - Wo ...

  • AKA NYC Limited

    Media Planner

    1 week ago

    AKA NYC Limited New York, United States

    **Media Planner** · AKA NYC is an award-winning, fully integrated advertising agency with unparalleled expertise across the arts & entertainment, leisure, travel, retail, and tourism sectors. With a focus on creativity, innovation, and consumer experiences, we have a proven recor ...

  • FGS Global

    Associate Director, Media Planning and Buying

    5 days ago

    FGS Global New York, United States

    **INTRODUCTION** · About FGS Global · - FGS Global is a strategic advisory and communications consultancy, with over 1200 multidisciplinary experts across the world's major financial, government, business, and cultural centers. The firm is an acknowledged leader in crisis, corpor ...