Director, Regulatory Advertising, Promotion & Labeling

Role: Director, Regulatory Advertising, Promotion & Labeling

Target Date of Hire: April 2024

The Opportunity:

We are seeking a highly skilled and experienced Director, Regulatory Advertising, Promotion & Labeling to join our dynamic team and play a pivotal role in driving the program to success. This role is responsible for leading and overseeing all regulatory activities, both strategic and tactical, related to advertising, promotion, and commercial labeling of our pharmaceutical products in compliance with regulatory standards, company policies, and applicable Industry Guidelines.

Primary Duties & Responsibilities:

• Provide regulatory leadership and guidance to global cross-functional teams during the development, review and approval of product labeling and advertising materials.
• In collaboration with Medical, Legal and Commercial, provide Regulatory leadership and oversight to ensure that regulatory requirements are integrated in product and disease-state communications.
• Provide a leadership role on the review committee, providing regulatory guidance on promotional labeling and advertising materials.
• Develop solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating and managing business risks.
• Work collaboratively with Compliance and Legal to ensure that materials approved are used within the intended guidelines.
• Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives.
• Ensure that changes in product labeling are carried into promotional materials in accordance with company procedures and regulatory requirements.
• Participate in training of sales and marketing personnel on promotional, labeling and advertising regulations.
• Serve as FDA liaison for matters related to the advertising and promotion of assigned products.
• Serve as a subject matter expert on relevant regulations, stays abreast of changes in the regulatory environment, and assesses impact of changes on business and product development programs.
• Proactively manages critical issues, taking leadership for regulatory adpromo contribution.
• Support the development of relevant policies, processes, and SOPs.

Minimum Experience & Education:

• Bachelor's degree and 10+ years pharmaceutical industry experience
• Direct experience with the implementation of promotional labeling and advertising regulations
• Hands-on experience in pharmaceutical promotion development and review process
• Comprehensive knowledge of global regulatory requirements, guidelines, and industry best practices, including FDA, EMA, ICH, and other relevant authorities

Preferred Experience & Education:

• MS degree with 8+ years pharmaceutical industry experience
• RAC certification
• Extensive experience in regulatory affairs within the pharmaceutical industry, with a focus on advertising, promotion, and labeling
• Proven track record of successfully leading and managing regulatory activities in a complex, global environment
• Excellent leadership and people management skills, with the ability to inspire and motivate teams to achieve goals.
• Strong understanding of pharmaceutical quality systems, GxP principles, and regulatory inspection processes
• Ability to provide strategic and operational leadership for the planning, management, support and execution of commercial regulatory activities globally

Skills & Qualifications:

• Strong team player with a demonstrated track record of success in a cross‐functional team and fast-moving environment
• Excellent organizational, computing, and oral/written communication skills
• Ability to influence and formulate effective solutions
• Strong critical thinking and decision-making skills
• Strong supervisory and leadership skills
• Ability to prioritize tasks and to delegate them when appropriate
• Ability to read and comprehend policies, procedures, instructions, etc., to write reports, to use logic and data to solve problems, to assess needs, and varying degrees of independence, judgment, and discretion.
• Proficient with Microsoft Office Suite or related software

Supervisory Responsibilities:

• Recruits, interviews, hires, and trains new staff
• Oversees the daily workflow of the department
• Provides constructive and timely performance feedback and evaluations
• Other related supervisory responsibilities as assigned

Work Location & Travel Requirements:

• This position may be home-office based (remote) or located in our Irvine, California office. If remote, the role is expected to be in the Irvine office at least once a quarter, or at such other frequency as required by business necessity or as reasonably required by the position's manager.
• Domestic and international travel will be required from time to time as needed (approximately [10-25]%).

Physical Requirements & Environmental Conditions:

• The duties of this role are generally conducted in an in-office and/or home-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 (in-person interactions with other persons in indoor and outdoor settings); stand and/or move about the office or in various environments (including tight and confined spaces) or from one worksite to another.
• Able to travel, including occasional international travel, without personal assistance.
• The above physical requirements and work environment characteristics generally reflect those of this position but is not an exhaustive list. Reasonable accommodations may be made to enable individuals with qualified disabilities to perform the essential functions of the position, provided that such accommodation does not impose an undue hardship on Reneo Pharmaceuticals.

Equal Employment Opportunity:

• As an equal opportunity employer, Reneo Pharmaceuticals, along with its subsidiaries, is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by applicable law. All employees, officers, and representatives of Reneo Pharmaceuticals are expressly prohibited from engaging in unlawful discrimination, harassment, or retaliation.
• Consistent with all applicable requirements, Reneo Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless doing so would create an undue hardship on the company.
• Reneo Pharmaceuticals also complies with all applicable federal, state and local laws governing work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and Immigration Reform and Control Act. Reneo Pharmaceuticals is an E-Verify employer.

The annual base salary range we reasonably expect to pay is $185,000 - $210,000 depending on qualifications and experience. This base salary range is an estimate, and the actual base salary may vary based on Company compensation practices. Individual pay decisions depend on various factors, such as years of relevant experience and skillset, complexity and responsibility of role, and job duties/requirements. In addition, the compensation for this position may also include eligibility for an annual cash bonus and participation in our equity program. Benefits offered include retirement savings plan (with company match), paid vacation, holiday and sick days, and health benefits to include medical, dental and vision coverage in accordance with the terms and conditions of the applicable plans.