Corporate Compliance Director manages the compliance programs, policies, reporting, and practices for an organization or business. Ensures that all activities follow regulatory requirements related to the governance of the organization as well as any industry-specific or location-specific laws. Being a Corporate Compliance Director oversees internal controls and auditing systems that monitor and report on regulated activities and processes. Implements risk-based compliance testing of existing procedures and controls to identify, detect, and correct noncompliance. Additionally, Corporate Compliance Director evaluates and implements changes to compliance processes due to new or amended regulations. Delivers communication and training initiatives that inform stakeholders about compliance requirements. Requires a bachelor's degree. Typically reports to a director. The Corporate Compliance Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Corporate Compliance Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
This is what you will do:
The Senior Director, Advertising and Promotional Compliance, will direct and conduct the regulatory affairs aspects of review and approval of promotional materials and marketing activities for all products in the Alexion portfolio and pipeline, including acquisition products. This individual will have primary responsibility for strategic planning and preparation of critical submission documentation with business partners and the health authorities ( U.S. Food and Drug Administration (“FDA”)). S/he will lead and direct the Regulatory Affairs Advertising and Promotional Compliance organization in support of the Alexion portfolio, pipeline, and therapeutic areas, and will develop and implement strategies to facilitate the development and review of promotional materials and activities. This position requires that the successful applicant possess expert knowledge of FDA promotional regulations to support assigned therapeutic area(s) (TA) and related business functions. This position will independently work with business senior leaders to provide regulatory guidance and risk assessment to help business teams develop and deliver initiatives that are intended to comply with applicable laws, rules and regulations governing the advertising and promotion of pharmaceutical products. This is a US role with team members based in the US. This is a leadership role in regulatory affairs interacting with commercial, medical and legal on a regular basis with very strong interactions occurring when in launch mode.
You will be responsible for:
Additional representative responsibilities will include, but not necessarily be limited to, the following:
You will need to have:
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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