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アッヴィは、現在の深刻な健康上の問題を解決し、将来の医療の課題に対応する革新的な医薬品を創薬し、お届けすることを使命としています。アッヴィは、傘下のアラガン・エステティックスのポートフォリオの製品やサービスに加え、免疫疾患、がん、神経疾患、眼科系疾患、ウイルス、女性の健康および消化器系疾患などいくつかの主要な治療分野において、人々の生活に大きな影響をもたらすため尽力しています。アッヴィに関する詳細は、当社公式ウェブサイト(www.abbvie.com)にアクセスしてご確認ください。また、ぜひTwitter、Facebook、Instagram、YouTube、LinkedInで当社アカウント(@abbvie)をフォローしてください。

Senior Manager, Regulatory Affairs US Advertising and Promotion (Irvine, CA or Remote)

Primary アーバイン, カリフォルニア州 Secondary ; Remote 求人ID 2211553 カテゴリー Regulatory Affairs 部門 AbbVie

The Senior Manager Regulatory Affairs US Advertising and Promotion, combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. Has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. Shares knowledge and expertise with others in support of team activities. Analyzes broad scope implications of changing regulations and policies.

  • Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in clear and concise manner.
  • Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.
  • Summarizes findings, under supervision, in concise reports for distribution within AbbVie
  • Oversees the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.
  • Develops and guides implementation strategies for promotional activities
  • Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Ensures departmental training and compliance with established regulations, guidance’s, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assist in the development, training and mentoring of staff members
  • Effectively presents pertinent information to appropriate cross-functional groups.
  • Effectively delivers difficult messages to commercial organization without damage to relationships
  • Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.


At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.


Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Travel: No
Job Type: Experienced
Schedule: Full-time
ABBVIE

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  • Regulatory Affairs, アメリカ合衆国削除
  • Regulatory Affairs, Remote削除
  • Regulatory Affairs, アーバイン, カリフォルニア州, アメリカ合衆国削除

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