Director, Global Regulatory Consulting - #1690751

At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us!

Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs.  We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.  

THE POSITION:

The Director, Global Regulatory Consulting 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 Consulting, 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams.  These results are achieved by partnering with clients to ensure their products or services meet governing regulations. Our work varies from client to client, but consistently draws upon regulatory expertise, research and organization skills, effective communication to a variety of roles and decision makers, and technical writing skills that transform complex products into simple descriptions. As the primary contact with each client, we also serve as the project manager, breaking complex deliverables into trackable tasks and then ensuring all project goals and timelines are achieved.

• 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.

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

EXPECTIONS OF THE JOB:

• Partner with clients to achieve business objectives. 
• Understand the client’s needs and recommend regulatory strategies and tactics.
• Cross functional collaboration to ensure objectives and milestones are met.
• Consultative services and selling to clients, ensuring positive front-line contact.
• Mentoring and knowledge sharing with other regulatory associates.
• Travel Up to 10% (may occasionally exceed 10%)
• Hours Average 40 hours per week

The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.

An individual in this position must be able to successfully perform the expectations listed above.

MINIMUM KNOWLEDGE, SKILLS, AND ABILITIES:

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

• Education
  • Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Experience and/or Training
  • Minimum of 10 years of experience in Regulatory Affairs or Regulatory Consulting in the pharmaceutical or biotech industry.
  • Proven experience in providing strategic regulatory advice to clients.
  • Applied expertise with 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 that 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.

PREFERRED QUALIFICATIONS:

• Education
  • Master’s, PhD, or PharmD degree in a scientific or business discipline 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 or biotech 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.
• Regulatory Affairs, Chemistry, Manufacturing, and Controls (CMC) Experience
  • Experience in CMC: Proven experience in the development and review of CMC regulatory documents for pharmaceutical and/or biotech products.
  • Knowledge of CMC Regulations: Familiarity with FDA and international regulations related to pharmaceutical and/or biotech 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 or biotech products.
  • Knowledge of FDA Regulations: Familiarity with FDA regulations related to advertising and promotion of pharmaceutical and biotech 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 and biotech products.
  • Knowledge of Labeling Regulations: Familiarity with FDA and international regulations related to pharmaceutical and biotech 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.

PHYSICAL/MENTAL DEMANDS AND WORKING ENVIRONMENT:

The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Office: While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands.

OUR CULTURAL BELIEFS:

Patient Minded I act with the patient’s best interest in mind.

Client Delight I own every client experience and its impact on results.

Take Action I am empowered and empower others to act now.

Grow Talent I own my development and invest in the development of others. 

Win Together I passionately connect with anyone, anywhere, anytime to achieve results.

Communication Matters I speak up to create transparent, thoughtful and timely dialogue.

Embrace Diversity I create an environment of awareness and respect.

Always Innovate I am bold and creative in everything I do.

EVERSANA is committed to providing competitive salaries and benefits for all employees. The anticipated base salary range for this position is $168,000 to $235,000 and is not applicable to locations outside of the U.S.  The base salary range represents the low and high end of the salary range for this position.  Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living).  EVERSANA reserves the right to modify this base salary range at any time.

From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility.

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