The Director, Labeling, Advertising and Promotion will be responsible for leading, initiating, reviewing and approving advertising and promotional materials to ensure compliance with product registrations and regulatory requirements throughout the product life-cycle. The candidate will be responsible for ensuring compliance with regulatory agencies requirements and meeting Akebia’s strategic promotional objectives. Additional responsibilities will include monitoring regulatory compliance trends in industry, interpreting new regulations, guidance documents and enforcement letters. The Director will coordinate regulatory training of commercial and marketing teams on regulatory issues pertaining to advertisement, promotion and product launch activities. The incumbent will work collaboratively with medical affairs, legal compliance, and commercial teams in the development and implementation of advertising and promotional materials for Akebia’s product portfolio that support the achievement of business objectives.  This role is expected to provide leadership, insight, sound judgment and clear directions on promotional programs and tactics that are compliant with regulations and company policies.  This role reports to the Sr. Director Regulatory Affairs.

Required Skills

• Serves as the primary regulatory advertising and promotion reviewer on cross-functional Promotional Review Committee (PRC) and Medical Review Committees (MRCs)

• Acts as primary contact with FDA's Office of Prescription Drug Promotion (OPDP), including responding to agency inquiries and managing company requests for advisory review.

• Develops solutions to complex US promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively managing business risks.

• Identifies and provides guidance on development and improvement of policies, processes, and standards for promotional materials and related activities.

• Works closely with Regulatory counterparts to ensure that global development strategies result in commercially viable labeling, in support of desired promotional claims.

• Maintain a deep and current awareness of evolving FDA regulations and interpretations, advisory comments, enforcement actions and policy issues affecting the medical device Industry

• Effectively partner with Medical Affairs, Legal Compliance, Commercial and International Distributors as needed to ensure promotional labeling, marketing advertisement and educational materials and are reviewed in a timely fashion throughout the product life-cycle

• Interpret and communicate regulatory perspective on advertising and promotional activities and risks to all stakeholders and management

• Ensure communications and promotional claims are in compliance with product registrations, applicable laws, regulations and policies and have sufficient substantiating evidence on file

• Serve as an internal expert on FDA guidance, regulations, and enforcement trends governing the promotion and advertising 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.  Act as Chair of PRC.

• Thoroughly review and assess proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements and Akebia 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 Office of Prescription Drug Promotion (“OPDP”) requirements, as well as a keen awareness of enforcement trends. Serve as primary contact leading and facilitating communications with the OPDP 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.

• In collaboration with global regulatory operations, ensure the management and maintenance of records and databases that support communication with OPDP.

• 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.

• Identify and escalate any unresolved regulatory affairs compliance concerns to the appropriate escalation committees Provides oversight to relevant external vendors and consultants.

• Monitors and keeps organization up-to-date on US regulatory promotional environment (e.g., the issuance of new FDA regulations/guidance, relevant FDA enforcement action and general awareness of industry practices, including those of competitors).

Required Experience

Basic Qualifications:

• BA/BS Degree
• A minimum of 8 years of pharmaceutical industry experience, with at least 5 years of regulatory affairs experience focused on the review of advertising and promotion materials for prescription drug products

Preferred Qualifications:

• Advanced degree preferred (MS, PhD, PharmD, or JD)

• Experience with launching new products and/or new indications

• Direct experience interacting with OPDP

• Strong interpersonal and oral and written communication skills

• Able to innovate, analyze, and solve problems with minimal supervisory input, anticipating and identifying regulatory risks and making recommendations to management, as appropriate

• Solid understanding of business goals and common marketing concepts/tools, including the internet and social media

• Expert understanding of FDA advertising and promotion regulations and guidelines specific to advertising and promotion of pharmaceutical products is required;

• Significant experience communicating and negotiating directly with the OPDP.

• Ability to listen to and carefully consider others’ perspectives and to manage and resolve conflict with sound judgment and risk assessment.

• Knowledgeable on industry compliance requirements and non-compliance examples and trends.

• Demonstrated ability to influence others and foster team collaboration.

Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com

Akebia Therapeutics is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

• Serves as the primary regulatory advertising and promotion reviewer on cross-functional Promotional Review Committee (PRC) and Medical Review Committees (MRCs)

• Acts as primary contact with FDA's Office of Prescription Drug Promotion (OPDP), including responding to agency inquiries and managing company requests for advisory review.

• Develops solutions to complex US promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively managing business risks.

• Identifies and provides guidance on development and improvement of policies, processes, and standards for promotional materials and related activities.

• Works closely with Regulatory counterparts to ensure that global development strategies result in commercially viable labeling, in support of desired promotional claims.

• Maintain a deep and current awareness of evolving FDA regulations and interpretations, advisory comments, enforcement actions and policy issues affecting the medical device Industry

• Effectively partner with Medical Affairs, Legal Compliance, Commercial and International Distributors as needed to ensure promotional labeling, marketing advertisement and educational materials and are reviewed in a timely fashion throughout the product life-cycle

• Interpret and communicate regulatory perspective on advertising and promotional activities and risks to all stakeholders and management

• Ensure communications and promotional claims are in compliance with product registrations, applicable laws, regulations and policies and have sufficient substantiating evidence on file

• Serve as an internal expert on FDA guidance, regulations, and enforcement trends governing the promotion and advertising 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.  Act as Chair of PRC.

• Thoroughly review and assess proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements and Akebia 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 Office of Prescription Drug Promotion (“OPDP”) requirements, as well as a keen awareness of enforcement trends. Serve as primary contact leading and facilitating communications with the OPDP 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.

• In collaboration with global regulatory operations, ensure the management and maintenance of records and databases that support communication with OPDP.

• 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.

• Identify and escalate any unresolved regulatory affairs compliance concerns to the appropriate escalation committees Provides oversight to relevant external vendors and consultants.

• Monitors and keeps organization up-to-date on US regulatory promotional environment (e.g., the issuance of new FDA regulations/guidance, relevant FDA enforcement action and general awareness of industry practices, including those of competitors).