Director, Global Regulatory Affairs

EVERSANA•Chicago, IL

19h•Remote

About The Position

THE POSITION : The Director, Global Regulatory Affairs collaborates with client’s project team members and key decision makers to gain a complete understanding of a product and transforms that knowledge into an actionable regulatory strategy. As a Director, Global Regulatory Affairs, you are also responsible for implementing the strategy, which often entails engaging regulatory authorities, authoring submissions, and interacting with the authorities throughout the regulatory review. This is a highly collaborative role, one in which you will often become an embedded member of the client’s organization where you will proactively be influencing and shaping the regulatory environment for business goals and strategies. This remote role prefers candidates based in the Eastern or Central Time Zones. ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:

Requirements

Bachelor’s degree in scientific discipline; advanced degree preferred.
Minimum of 10 years of experience in Regulatory Affairs or Regulatory Consulting in the pharmaceutical industry.
Proven experience in providing strategic regulatory advice to clients.
Applied expertise within the product development life cycles.
Effective verbal and written communication skills with internal and external stakeholders; strong negotiation and influencing skills.
Ability to explain reasoning led to conclusions in both written and oral formats.
Strong project management skills; knowledge and implementation of process and planning best practice; ability to manage risk and communicate it effectively.
Ability to manage multiple projects, priorities, and deliverables in a timely fashion.
Prudent and practical decision-making abilities, a team player, and can work independently without direct supervision.
Self-motivation, good judgment, strong follow-up, organizational, analytical, and problem-solving skills.
Excellent leadership, communication, and interpersonal skills.

Nice To Haves

Master’s, Ph.D., or PharmD degree in a scientific area or business discipline preferred.
Candidates are not required to have experience in all regulatory functional areas listed below; however, demonstrated expertise across multiple domains (e.g., Clinical, CMC, Ad/Promo, Labeling, or Generalist Regulatory functions) is strongly preferred.
Regulatory Affairs, Generalist Experience Broad Regulatory Knowledge: Familiarity with a wide range of regulatory topics, including but not limited to CMC, labeling, ad/promo, and clinical trial regulations.
Experience in Regulatory Affairs: Proven experience in the development, review, and submission of regulatory documents for pharmaceutical products.
Cross-Functional Collaboration: Ability to work cross-functionally with various teams such as clinical, manufacturing, quality, and research/development to ensure regulatory compliance.
Regulatory Strategy: Experience in developing and implementing regulatory strategies in alignment with product development and post-marketing activities.
Global Regulatory Knowledge: Strong knowledge of global regulatory guidelines and requirements, and experience in negotiations with health authorities.
Clinical Regulatory Affairs Experience in Clinical Regulatory Submissions: Proven experience preparing, reviewing, and submitting clinical regulatory documents, including INDs, CTAs, protocols, investigator brochures, safety reports, and clinical amendments.
Knowledge of Clinical Regulations: Strong familiarity with FDA, EMA, ICH, and other global clinical regulatory requirements governing clinical trial design, conduct, safety reporting, and GCP compliance.
Clinical Development Strategy: Experience developing clinical regulatory strategies to support early- and late‑stage development programs, including advice on study design, endpoints, and regulatory pathways.
Health Authority Interactions: Experience preparing for and participating in health authority meetings (e.g., FDA, EMA, MHRA), including drafting meeting requests, briefing packages, and responses to information requests.
Cross-Functional Collaboration: Ability to work effectively with clinical operations, safety/pharmacovigilance, biostatistics, medical writing, and clinical development teams to ensure regulatory alignment throughout clinical studies.
Clinical Trial Lifecycle Management: Expertise supporting all phases of clinical development, from first‑in‑human through pivotal studies, including regulatory oversight of trial initiation, conduct, safety reporting, and closeout.
Global Clinical Regulatory Knowledge: Strong understanding of regional differences in clinical trial requirements and experience supporting multinational and global clinical programs.
Regulatory Affairs, Chemistry, Manufacturing, and Controls (CMC) Experience Experience in CMC: Proven experience in the development and review of CMC regulatory documents for pharmaceutical products.
Knowledge of CMC Regulations: Familiarity with FDA and international regulations related to pharmaceutical product CMC.
CMC Strategy: Experience in developing strategic CMC objectives in alignment with product development and post-marketing activities.
Cross-Functional Collaboration: Ability to work cross-functionally with manufacturing, quality, and research/development teams to ensure the accuracy and compliance of CMC data.
Global CMC: Strong knowledge of global CMC guidelines and requirements, and experience with CMC negotiations with health authorities.
Regulatory Affairs, Advertising/Promotion Experience Experience in Ad/Promo: Proven experience in regulatory review of promotional and advertising materials for pharmaceutical products.
Knowledge of FDA Regulations: Familiarity with FDA regulations related to advertising and promotion of pharmaceutical products.
Strategic Input: Experience in providing strategic input on promotional materials and activities to ensure compliance with regulatory requirements.
Cross-Functional Collaboration: Ability to work cross-functionally with medical, legal, and marketing teams to ensure regulatory compliance of promotional strategies.
Global Guidelines: Knowledge of global guidelines and requirements related to pharmaceutical advertising and promotion.
Regulatory Affairs, Labeling Experience Experience in Labeling: Proven experience in the development and review of labeling for pharmaceutical products.
Knowledge of Labeling Regulations: Familiarity with FDA and international regulations related to pharmaceutical product labeling.
Labeling Strategy: Experience in developing strategic labeling objectives in alignment with product development and post-marketing activities.
Cross-Functional Collaboration: Ability to work cross-functionally with medical, legal, and marketing teams to ensure the accuracy and compliance of product labels.
Global Labeling: Strong knowledge of global labeling guidelines and requirements, and experience with label negotiations with health authorities.

Responsibilities

Deliver full-service oversight and consultation to clients by providing strategic regulatory considerations and paths to market, combined with a commitment to getting products approved in various regions.
Collaborate with clients’ project team members and key decision makers to gain a complete understanding of the product and goals and transform that knowledge to a strategy that balances risk with potential regulatory outcomes of proposed paths in a way that clients can understand and apply in decision making.
Identify, propose, plan, and direct regulatory projects, transforming the regulatory strategy into executable project plans that achieve desired results and timelines.
Serve as a trusted intermediary with health authorities to build and maintain a positive relationship on behalf of clients.
Negotiate with health authorities during the development and review processes to ensure productive submission process.
Establish and maintain healthy, long-term relationships with clients to generate repeat business and referrals.
Support business development efforts as a Sales SME, applying expertise and performing presentations that demonstrate the benefits of our services to potential clients, and support proposal development for new opportunities.
Remain current on global regulatory requirements and approval processes.
Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.
All other duties as assigned