BioSpace · 12 hours ago
Senior Manager, Regulatory Affairs US Advertising & Promotion (remote)
Maximize your interview chances
BiotechnologyCommunities
Comp. & Benefits
Insider Connection @BioSpace
Get 3x more responses when you reach out via email instead of LinkedIn.
Responsibilities
Reviews promotional and non-promotional communications for on-market products to ensure compliance with applicable laws and regulations, as well as internal policies and procedures. Functions independently in this role while bringing relevant topics to management as appropriate.
Provides regulatory guidance for data and information consistent with product labeling.
Participates in pipeline commercialization activities; reviews and contributes to target product claims, target product labeling.
Acts as a key contributor on cross-functional teams and workstreams for pipeline and on-market products.
Develops and guides implementation strategies for promotional activities.
Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVies interests. Maintains awareness of pending changes to communicate impact and relevance within US Advertising and Promotion department.
Represents department and participates in trade associations as needed.
Summarizes findings, under supervision, in concise reports for distribution within AbbVie.
If assigned staff, oversees their operations, productivity, and development.
Ensures departmental training and compliance with established regulations, FDA guidance, promotional guidelines, and SOPs related to advertising and promotion regulations. If applicable, 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 while maintaining relationships.
Establishes good working relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Market Access, Public Affairs, etc.), fostering mutually beneficial interactions and exchange.
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
Bachelors degree in science (biology, chemistry, microbiology immunology, medical technology pharmacy, pharmacology, nursing, pharmacy)
Strong communication skills, both oral and written
Preferred
Relevant Masters degree (Pharmacy, advanced scientific or law)
7 years pharmaceutical experience in Regulatory Affairs or related area
Experience working in a complex and matrix environment and exhibits strong negotiation skills
Experience in management capacity
Experience in US Regulatory Affairs Advertising and Promotion
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Company
BioSpace
BioSpace is the leading online community for industry news and careers for life science professionals.
Funding
Current Stage
Growth StageTotal Funding
$10M2000-08-24Series B· $10M
Recent News
Crunchbase News
2024-11-20
2024-05-31
Company data provided by crunchbase