Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology
Allergan, Irvine, CA, United States
Senior Manager Regulatory Affairs US Advertising and Promotion–Immunology
Combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. Leads the department as a subject matter expert (SME) for Regulatory.
Responsibilities
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. Draft and finalize comments in a timely manner to regulators and trade associations. Distribute proposed policies to SMEs. Highlight key points in a 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 responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies, 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 across therapeutic areas.
Ensures departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members.
Effectively presents pertinent information to appropriate cross‑functional groups.
Effectively delivers difficult messages to commercial organizations without damaging 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.
Qualifications
Minimum: Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g., regulatory affairs fellowship, Health Authority, ad promo, etc.).
Preferred: PharmD degree plus 5 years of relevant industry experience (e.g., regulatory affairs fellowship, Health Authority, ad promo, etc.).
Experience working in a complex and matrix environment and exhibits strong negotiation skills.
Strong communication skills, both oral and written.
Experience in management capacity preferred.
Experience in US Regulatory Affairs Advertising and Promotion.
Benefits
Compensation range described is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of posting based on the job grade. Individual compensation paid within this range will depend on many factors including geographic location. This range may be modified in the future.
Comprehensive package of benefits: paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
Eligible to participate in short‑term incentive programs.
Equal Opportunity Employer Statement 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 applicants seeking a reasonable accommodation can learn more at the provided link.
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Responsibilities
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. Draft and finalize comments in a timely manner to regulators and trade associations. Distribute proposed policies to SMEs. Highlight key points in a 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 responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies, 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 across therapeutic areas.
Ensures departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members.
Effectively presents pertinent information to appropriate cross‑functional groups.
Effectively delivers difficult messages to commercial organizations without damaging 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.
Qualifications
Minimum: Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g., regulatory affairs fellowship, Health Authority, ad promo, etc.).
Preferred: PharmD degree plus 5 years of relevant industry experience (e.g., regulatory affairs fellowship, Health Authority, ad promo, etc.).
Experience working in a complex and matrix environment and exhibits strong negotiation skills.
Strong communication skills, both oral and written.
Experience in management capacity preferred.
Experience in US Regulatory Affairs Advertising and Promotion.
Benefits
Compensation range described is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of posting based on the job grade. Individual compensation paid within this range will depend on many factors including geographic location. This range may be modified in the future.
Comprehensive package of benefits: paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
Eligible to participate in short‑term incentive programs.
Equal Opportunity Employer Statement 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 applicants seeking a reasonable accommodation can learn more at the provided link.
#J-18808-Ljbffr