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Director Regulatory Affairs

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position. 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.

ACTIVE

<br/><div>Company Description</div><br/><p>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<a href="#" rel="nofollow">www.abbvie.com</a>. Follow @abbvie on<a href="#" rel="nofollow">X</a>,<a href="#" rel="nofollow">Facebook</a>,<a href="#" rel="nofollow">Instagram</a>,<a href="#" rel="nofollow">YouTube</a>,<a href="#" rel="nofollow">LinkedIn</a>and<a href="#" rel="nofollow">Tik Tok</a>.</p><br/><div>Job Description</div><br/><p>The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge; collects and analyzes issues and trends that affect the business. This individual identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge.</p><p>Responsibilities:</p><ul><li>Make decisions and plans for operations (work flow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives.</li><li>Maintains and evaluates productivity metrics to project current and future business needs</li><li>Aligns and maintains effective communication channels with key Medical, Marketing, Regulatory, Legal and Public Affairs counterparts. Identifies areas of improvement in process/policy, develops recommendations/plan, and leads initiatives.</li><li>Assists in the management of the departmental budget, identifies and communicates budgetary needs to Operations and Finance, and identifies and projects current and future expenditures and business needs.</li><li>Collects and analyzes issues/trends that affect business to identify and act on cross-organization or cross business opportunities. Effective use of knowledge of global marketplace, technology and business levels.</li><li>Operates independently, with recognition of when to consult departmental senior concerning risks. In absence of Director, is responsible for day-to-day operations. Responsible for departmental initiatives, which have significant impact on both internal and external customers.</li><li>Encourages innovation and holds employees accountable for delivering on their goals; recognizes, mentors, rewards and recommends promotion for staff members based on their performance, results, and development.</li><li>Exhibits solid understanding of regulations, and guidance of regulatory authorities, political and legal climate and industry practices related to advertising and promotions to assist in meeting organizational goals. Possesses and leverages broad industry knowledge</li><li>Develops and implements complex processes and projects and develops and delivers strategic presentations for senior management</li><li>Identifies areas of improvement in process, policy, develops recommendations/plan and leads initiatives</li></ul><p>Significant Work Activities:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required</p><br/><div>Qualifications</div><br/><ul><li>Bachelor’s degree plus 8+ years of relevant experience (e.g. Applicable pharmaceutical/medical devices/biologics experience, pharmacy rotations Public Health, etc.)</li><li>Advanced degree preferred: MS, MPH, MSN, PA, DNP, PhD, PharmD, JD, MD degree plus 6 years of relevant industry experience. Certification a plus</li><li>Experience in US Regulatory Affairs Advertising and Promotion preferred</li><li>Experience working in a complex and matrix environment</li><li>Strong communication skills, both oral and written</li><li>Experience developing and implementing successful global regulatory strategies</li><li>Experience in management capacity preferred</li></ul><br/><div>Additional Information</div><br/><p>Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:</p><ul><li><p>The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.</p></li><li><p>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.</p></li><li><p>This job is eligible to participate in our short-term incentiveprograms.</p></li><li><p>This job is eligible to participate in our long-term incentiveprograms</p></li></ul><p>Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable law.</p><p>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.</p><p>US & Puerto Rico only - to learn more, visit<a href="#" rel="nofollow">https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html</a></p><p>US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:</p><p><a href="#" rel="nofollow">https://www.abbvie.com/join-us/reasonable-accommodations.html</a></p>#J-18808-Ljbffr

Allergan

Associate Director, Regulatory Affairs Advertising & Promotion - Immunology

JobLeads

Regulatory Affairs Manager

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. The Senior Manager of Regulatory Affairs US Advertising and Promotion in Immunology-Dermatology combines scientific, regulatory, and business expertise to ensure that products meet all required legislation.

<div>Company Description</div><br/><p>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 <a href="#" rel="nofollow">www.abbvie.com</a>. Follow @abbvie on <a href="#" rel="nofollow">X</a>, <a href="#" rel="nofollow">Facebook</a>, <a href="#" rel="nofollow">Instagram</a>, <a href="#" rel="nofollow">YouTube</a>, <a href="#" rel="nofollow">LinkedIn</a>, and <a href="#" rel="nofollow">TikTok</a>.</p><br/><div>Job Description</div><br/><p>The Senior Manager of Regulatory Affairs US Advertising and Promotion in Immunology-Dermatology combines scientific, regulatory, and business expertise to ensure that products meet all required legislation. The role involves developing and supervising regulatory professionals, supporting efforts to influence the regulatory environment, and serving as a subject matter expert (SME) in Regulatory. The individual shares knowledge with team members and analyzes the implications of regulatory changes.</p><p>Responsibilities include:</p><ol><li>Monitoring and communicating updates from government, industry, and trade associations affecting pharmaceutical regulations; drafting and sharing comments and policy summaries.</li><li>Representing the department in trade associations and developing relationships with trade managers.</li><li>Preparing concise reports on regulatory findings for internal distribution.</li><li>Overseeing regulatory staff responsible for advertising and promotion materials to ensure accuracy, competitiveness, and compliance with CFR, FDA guidance, PhRMA principles, and the FDA and Cosmetic Acts.</li><li>Developing strategies for promotional activities and applying broad regulatory/technical knowledge across therapeutic areas.</li><li>Ensuring departmental training and compliance with regulations, SOPs, and promotional guidelines; managing and mentoring staff.</li><li>Presenting information effectively to cross-functional teams and managing difficult communications with commercial groups.</li><li>Building strong relationships with management and stakeholders across Marketing, Medical, Legal, Sales, and other departments.</li></ol><p>Significant Work Activities:</p><p>Prolonged sitting (more than 2 hours in an 8-hour day) is required.</p><br/><div>Qualifications</div><br/><ul><li>Minimum: Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, nursing) plus 7 years of relevant industry experience.</li><li>Preferred: PharmD degree plus 5 years of relevant experience.</li><li>Experience in complex, matrix environments with strong negotiation skills.</li><li>Excellent communication skills, both oral and written.</li><li>Management experience preferred.</li><li>Experience in US Regulatory Affairs Advertising and Promotion preferred.</li></ul><br/><div>Additional Information</div><br/><p>Includes pay disclosure details as per applicable laws, benefits, and participation in incentive programs. All compensation details are at the company's discretion and subject to change.</p><p>AbbVie is an equal opportunity employer committed to integrity, innovation, and community service. For more details, visit <a href="#" rel="nofollow">https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html</a> and <a href="#" rel="nofollow">https://www.abbvie.com/join-us/reasonable-accommodations.html</a>.</p>#J-18808-Ljbffr

Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology - Dermatology

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Allergan

Allergan