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Senior Manager, Regulatory Affairs job at reputed company in Mettawa, IL, Irvine, CA

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Title: Senior Manager, Regulatory Affairs - US Advertising and Promotion Location: reputed company Chicago, IL, USAEmployees work in a hybrid mode Full-time Salary Min: 121000 Therapy Area: Eye Care Salary Max: 230000_inactive reputed company Global Grade: 19 Compensation: USD 121,000 - USD 230,000 - yearly Job Description: About reputed company reputed company's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of reputed company. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about reputed company, please visit us at www.reputed company.com. Follow @reputed company on reputed company, reputed company, Instagram, X and YouTube.

Job Description

The Senior Manager, Regulatory Affairs US Advertising and Promotion - Eye Care combines knowledge of scientific, regulatory and business issues to reputed company products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager 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. This individual shares knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies. Responsibilities: Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to reputed company's interests. Maintains awareness of pending changes to communicate impact and relevance reputed company Regulatory Operations. Drafts and finalizes comments in a timely manner to regulators and trade associations. Distributes proposed policies to SMEs. Highlights 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 reputed company reputed company. 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 Federal Food, Drug, 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, promotional guidelines and SOPs reputed company to advertising and promotion regulations for self and direct reports (where applicable). Manages direct reports (where applicable) 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 reputed company organizations without damage to relationships Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) by fostering mutually beneficial interactions and exchange This role will work a hybrid work schedule from our Mettawa, IL; Florham Park, NJ or Irvine, CA reputed company headquarters. Significant Work Activities: reputed company sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

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 reputed company and matrix environment and exhibits strong negotiation skills Strong communication skills, both oral and written Experience in management reputed company preferred Experience in US Regulatory Affairs Advertising and Promotion Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation reputed company described below is the reputed company of possible reputed company pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid reputed company this reputed company will depend on many factors including geographic location, and we may ultimately pay more or less than the posted reputed company. This reputed company may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/reputed company insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No reputed company of pay is considered to be wages or compensation until such reputed company is earned, reputed company, and determinable. The reputed company and availability of any bonus, commission, incentive, benefits, or any other reputed company of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. reputed company is an equal opportunity employer and is committed to operating with reputed company, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. Apply tot his job Apply To this Job

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