Xeris Pharmaceuticals

Associate Director, Regulatory Affairs - Advertising & Promotion

Xeris Pharmaceuticals • $174K — $232K *
Chicago, IL 60629In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific discipline; advanced degree preferred
  • Minimum of 7 years in Regulatory Affairs with a focus on advertising and promotional regulations
  • Experience negotiating with OPDP and performing risk assessments
  • Demonstrated experience in developing global regulatory strategies
  • Strong knowledge of FDA regulations regarding advertising and promotional materials
  • Experience with labeling development and life-cycle management
  • Familiarity with AI technologies or AI-enabled process improvements preferred

Responsibilities

  • Lead development and oversight of regulatory review processes for promotional materials
  • Strategically support the creation and approval of FDA prescribing information and patient labeling
  • Review external communications and marketing materials for regulatory compliance
  • Train sales and marketing teams on advertising procedures and FDA guidance
  • Represent the company on current regulatory issues in advertising
  • Manage the copy review and approval process for promotional materials
  • Contribute to corporate policies regarding promotional materials and external communications
  • Develop SOPs for review, approval, and submission of advertising materials

Benefits

  • Flexible work environment with hybrid model
  • Opportunity for career advancement in Regulatory Affairs
  • Exposure to strategic decision-making and leadership roles
  • Collaborative company culture with cross-functional teamwork
  • Access to innovative technologies and industry best practices
Full Job Description
Job Description:

The Associate Director, Regulatory Affairs - Advertising & Promotion is the regulatory expert who is responsible for strategically leading functional and cross-functional partners during advertising and promotional activities. They coordinate the development and implementation of regulatory strategies for promotion and advertising plans and are a leader in the review process to support approval and dissemination of marketed product promotional material. Liaises with FDAs Office of Prescription Drug Promotion (OPDP) for Advertising and Promotion submissions.

Essential Job Functions
  • Leads the development and oversight of the processes and procedures relevant to the creation, review, and approval of advertising and promotional materials as part of Xeris' Regulatory review process and other external communication to ensure regulatory compliance.
  • Strategically supports the development and oversight of the processes and procedures relevant to the creation, review, and internal approval of FDA-approved prescribing information, Medication Guides, and patient labeling.
  • Reviews external communications materials, sales, and marketing materials, including training, for compliance to current regulations and guidance.
  • Lead in training of sales and marketing personnel on advertising and promotional procedure, industry best practices, and FDA guidance and trends in drug promotion.
  • Represents the company to outside customers and agencies and makes presentations as needed on current regulatory issues pertaining to advertising and promotional activities.
  • Provides leadership for and manages regulatory aspects of the copy review / approval process for promotional materials; ensures compliance of promotional materials with FDA laws, regulations, and published guidance documents.
  • Contributes to the development and implementation of corporate policies and procedures for regulation of promotional materials and other external communications/press releases.
  • Develops and maintains SOPs and processes for review, approval, and submission of advertising and promotional material. Works closely with the Legal, Medical Affairs, and Commercial business units on improving and enhancing the review process and associated system, and on establishing consistent best practices.
  • Leads coordination and training of employees on regulatory issues pertaining to promotion of company products.


Skills and Qualifications
  • Bachelor's degree in a scientific discipline; advanced degree preferred.
  • A minimum of 7 years of progressively responsible Regulatory Affairs experience with a focus on advertising and promotional regulations.
  • Experience communicating and negotiating directly with OPDP and performing risk assessments.
  • Significant demonstrated experience developing and executing complex and innovative global regulatory strategies, assessing & communicating risk/benefit to senior management, and influencing organizational direction as it pertains to compliance of advertising and promotion materials.
  • Experience with labeling development and life-cycle management.
  • Strong knowledge of US regulatory environment and FDA regulations and guidance regarding advertising and promotional materials for Drugs, Biologics, and Medical Devices.
  • Experience with artificial intelligence (AI) technologies or AI-enabled process improvements highly desirable
  • Competencies: Strategic Leadership, Teamwork & Collaboration, Attention to Detail, Self-Starter, Negotiation skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications, Presentation skills


Working Conditions
  • Position may require periodic evening and weekend work, as necessary to fulfill obligations.
  • Periodic overnight travel.
  • This position is based in Xeris' Chicago office and requires a minimum of two days per week in the office.


NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The anticipated base salary range for this position is $174,000 to $232,000.

#LI-HYBRID

About Xeris Pharmaceuticals

Xeris Pharmaceuticals is a specialty pharmaceutical company that develops and commercializes ready-to-use injectable and infusible drug formulations. The company's proprietary XeriSol and XeriJect formulation technologies allow for the subcutaneous and intramuscular delivery of highly concentrated, non-aqueous, ready-to-use formulations of peptides, proteins, antibodies, and small molecules using commercially available syringes, auto-injectors, multi-dose pens, and infusion pumps. Xeris' lead product, Gvoke HypoPen, is the first ready-to-use glucagon injection for the treatment of severe hypoglycemia in diabetes patients. The company is also developing a pipeline of other ready-to-use injectable and infusible drug formulations for various indications, including epilepsy, hypoglycemia, and post-operative pain management.
Learn more about Xeris Pharmaceuticals
Size
294 employees
Market Cap
$159 million
Industry
Pharmaceuticals & Biotech
Net Income
-$91.1 million
Founded
2005
5 Year Trend
+115.2%
Revenue
$20.4 million
NASDAQ
XERS
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Xeris Pharmaceuticals

More Pharmaceuticals & Biotech Jobs

Find similar Associate Director, Regulatory Affairs - Advertising & Promotion jobs:

NationwideChicago, IL