Regulatory Affairs Director jobs in Massachusetts

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:

• Serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drugs.
• In collaboration with Commercial, Medical and Legal colleagues, conduct a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims and assess consistency of proposed claims with approved labeling.
• Provide regulatory leadership to the respective cross-functional team charged with advertising and promotion review to ensure compliance of promotional materials including, but not limited to, Physician and Patient Sales, Marketing and Educational Materials, Training Materials, Slide Presentations and press releases and external communications in compliance with global  regulations and Company policies for ad promo materials
• Thoroughly review and assess proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements and Alexion policies; review and revise regulatory policies to ensure compliance with regulatory requirements.
• Contribute to the modification, development and implementation of Company practices and policies for advertising and promotional activities. 
• Assist Commercial with the planning and prioritization of proposed promotional and disease state materials; provide expert guidance related to Regulatory strategy during early development projects to ensure promotional goals can be achieved.
• Serve as a member of the Medical Review Committee to ensure regulatory compliance for non-branded, diseases specific or investigational drug communications.
• Maintain a thorough understanding of the FDA’s Office of Prescription Drug Promotion (“OPDP”) in the Center for Drug Evaluation and Research (CDER) and Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER) requirements, as well as a keen awareness of enforcement trends. Serve as primary contact leading and facilitating communications with the OPDP and APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products, including pre-clearance of launch materials or materials requiring pre-clearance such as products under Subpart H or Subpart E approval.
• In collaboration with global regulatory operations, ensure the management and maintenance of records and databases that support communication with OPDP and APLB.
• Provide consistent, well-supported, and clear guidance to key stakeholders.
• Deliver Regulatory compliance training to assigned teams in preparation for scientific conferences on and off site.
• Participate in developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials.
• Collaborate with global regulatory operations and cross-functional colleagues to assess and optimize use of electronic review and archiving tools.
• Provide input, review and approve web-based materials.
• Identify and escalate any unresolved regulatory affairs compliance concerns to the Vice President, US Medical Affairs.

You will need to have:

• Bachelor’s degree is required.
• 7-10 years of relevant industry experience which shall include demonstrated regulatory affairs experience specific to Advertising and Promotion Compliance is required
• Expert understanding of global ad prom regulations and guidelines specific to advertising and promotion of pharmaceutical products is required;
• Significant experience communicating and negotiating directly with the OPDP.
• A solutions-driven mindset with the ability to transform a requirement into a proposal and to be perceived as a constructive colleague who helps state ideas at the outset.
• A highly collaborative mindset; self-aware, emotionally intelligent and a good listener open to ideas and an exchange of meaningful dialogue with peers.
• Ability to listen to and carefully consider others’ perspectives and to manage and resolve conflict.
• A proven track record of practicing sound judgment as it relates to risk assessment
• Knowledgeable on industry compliance requirements and non-compliance examples and trends.
• Demonstrated ability to influence others and foster team collaboration.
• Strong interpersonal, communication and leadership skills.
• Ability to work in a fast-paced environment and to manage multiple competing tasks and demands.
• Forward thinker with strong industry knowledge and ability to identify, synthesize and act upon strategic information and changes within the environment.
• Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of cultures and disciplines.
• Demonstrated decision-making and problem-solving capability; ability to negotiate skillfully to achieve a fair outcome or promote a common cause.
• Demonstrated ability to represent Alexion’s interests, objectives and policies in a professional and responsible manner.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

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.