Senior Manager, Regulatory Affairs

Allergan; Lincoln (NE); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Advertising and Promotion Lead to ensure compliance and effectiveness in promotional activities. This role involves providing regulatory insight, collaborating with cross-functional teams, and leading process improvements in a dynamic environment. The ideal candidate will have extensive experience in pharmaceutical advertising regulations and a proven track record in leadership. Join a forward-thinking organization that values innovation and integrity, and make a significant impact on the future of healthcare solutions.

Qualifications

• 8-10 years of pharmaceutical experience with advertising and promotion.
• Solid understanding of regulatory advertising and promotion regulations.

Responsibilities

• Ensure promotional materials adhere to regulations and internal policies.
• Collaborate across functions to provide regulatory expertise.

Skills

Regulatory Advertising and Promotion

Problem Solving

Cross-functional Collaboration

Communication Skills

Leadership

Education

Bachelor's Degree in Science

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Role Overview

The China Regulatory Affairs Advertising and Promotion Lead will be responsible for ensuring promotional and non-promotional materials and activities for the China Allergan Aesthetics organization are fair, balanced, factually accurate and adhere to the National Medicinal Products Administration regulations and internal AbbVie policies.

Responsibilities

1. Provides regulatory position, perspective, and expertise related to advertising and promotion in China to internal and external customers/business partners. Maintains current knowledge of local codes of practice, regulations and guidances that impacts pharmaceutical and medical device advertising and promotion in China.
2. Collaborates and communicates effectively through all levels of management across multiple functions (Commercial, Medical, Legal, and Compliance). Recognized by organizational counterparts as a key company resource on pharmaceutical and medical device advertising and promotion.
3. Applies novel and creative methods to problem solving. Constantly searches for out of the box solutions while maintaining quality and adherence to regulations. Balances business needs and risk assessments with creative decision-making abilities.
4. Identifies and leads process improvement initiatives to support increased agility in the promotional review process.
5. Responsible for assigned marketed and development programs’ advertising and promotion strategies in China. Proactively works with cross-functional partners (Commercial, Medical, Legal, and Compliance) to provide sound representation of China Regulatory Advertising and Promotion position within and external to Allergan Aesthetics. Defines boundaries of accepted risk tolerance within assigned programs.
6. Provide input into brand strategy and key asset and therapy area initiatives, as required.
7. Reviews and evaluates the industry environment (e.g., regulatory, legal, and political climate) and competitive landscape (e.g. product strategies, commercial messages, positioning, etc.). Provides functional input on key initiatives impacting other areas. Leads the implementation of risk management strategies and risk management plans for advertising and promotion activities in China.
8. Share best practice and contribute to the development of marketing campaigns from concept creation and through execution in collaboration with cross-functional partners.
9. Supports departmental and business strategies, quality initiatives, compliance with policies and procedures, and the implementation of improvement plans. Contributes to the evaluation of departmental needs and implements solutions to enhance and facilitate operations.
10. Creates an environment to attract, retain, empower and mentor future leaders.

Qualifications

1. Preferred 8-10 years of pharmaceutical experience with advertising and promotion regulatory experience
2. Minimum Bachelor's Degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), is required.
3. The candidate must have a solid understanding of regulatory advertising and promotion regulations, having had direct responsibility in this area.
4. Strong management skills and multi-disciplinary team management. Proven 3 years in a leadership role preferred
5. Experience with products at different stages of the life-cycle
6. Experience working in a complex and matrix environment
7. Strong communication skills, both oral and written

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html