Regulatory Specialist

Regulatory Specialist

Job Description

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Regulatory Specialist

Job#: 3056987

Job Description:

Job Description: Global Regulatory Lead / U.S. Regulatory Lead (Cardiovascular Program)

Position Summary

We are seeking an experienced Global Regulatory Lead (GRL) and/or U.S. Regulatory Lead (USRL) to provide strategic regulatory leadership for a late-stage cardiovascular development program. This individual will serve as the primary regulatory lead for a key investigational cardiovascular asset and will drive global regulatory strategies through critical development and registration milestones, including NDA preparation, submission, and review activities.

The ideal candidate will have a strong regulatory background in cardiovascular drug development, extensive experience leading global regulatory strategies, and a proven track record of successful interactions with health authorities.

Pay Rate: 112/hr

Key Responsibilities

• Global Regulatory Leadership

• Serve as the Global Regulatory Lead (GRL) and/or U.S. Regulatory Lead (USRL) for a late-stage cardiovascular development program.

• Lead and execute global regulatory strategies that align with development, clinical, and business objectives.

• Provide strategic regulatory leadership throughout major development milestones, including:

• Database Lock (DBL)

• NDA preparation

• NDA submission

• Regulatory review activities

• Lead and facilitate Global Regulatory Teams (GRTs), driving effective collaboration, decision-making, and execution across internal and external stakeholders.

• Ensure regulatory strategies are integrated across functional teams and global regions.

• NDA Submission & Regulatory Strategy

• Drive regulatory readiness and execution for original NDA submissions.

• Provide oversight of global submission activities, including:

• Integrated submission planning

• Cross-functional coordination

• Risk identification and mitigation

• Submission governance and execution

• Develop product registration strategies and convert them into operational regulatory plans.

• Evaluate alternative regulatory pathways and create risk mitigation strategies to achieve development objectives.

• Lead U.S. regulatory planning and submission activities.

• Health Authority Engagement

• Develop and execute global and U.S. health authority engagement strategies.

• Lead interactions with regulatory agencies in partnership with regional and local regulatory teams.

• Serve as the primary regulatory subject matter expert (SME) for agency communications, regulatory risks, and submission approaches.

• Support the preparation of:

• Briefing documents

• Regulatory meeting materials

• Health authority responses

• Agency correspondence

• Cross-Functional Collaboration

• Collaborate with clinical, nonclinical, biostatistics, medical, commercial, and development teams to ensure regulatory considerations are incorporated into program plans.

• Influence internal stakeholders and external partners on strategic regulatory decisions.

• Operate effectively within complex partnership environments, aligning governance, regulatory strategy, and execution plans across organizations.

• Lead resolution of critical regulatory issues through effective stakeholder engagement and expert consultation.

• Strategic Regulatory Support

Provide regulatory guidance and input for:

• Clinical Study Protocols
• Clinical Study Reports (CSRs)
• Statistical Analysis Plans (SAPs)
• Nonclinical Reports and Summaries
• Clinical Summary Documents
• NDA and other global regulatory submissions

Contribute to the development of:

• Target Product Profiles (TPPs)

• Company Core Data Sheets (CCDS)

• U.S. labeling strategies

• Global labeling strategies

• Country-specific labeling requirements

• Required Qualifications

• PhD, MD, PharmD, MS, or BS in a relevant scientific discipline.

• Significant Regulatory Affairs experience (typically 4-7+ years, preferably more in a leadership capacity).

• Prior experience supporting cardiovascular drug development programs.

• Experience serving as:

• Global Regulatory Lead (GRL), and/or

• U.S. Regulatory Lead (USRL)

• Demonstrated experience leading major regulatory submissions and health authority interactions.

• Preferred Qualifications

• Proven success developing and implementing global regulatory strategies that support clinical development and successful product registration.

• Strong understanding of global regulatory requirements and submission processes.

• Experience communicating regulatory strategy, risks, and recommendations to executive and senior leadership.

• Demonstrated ability to lead large, complex matrix teams across functions and geographies.

• Ability to translate complex scientific and regulatory issues into actionable business recommendations.

• Successful track record negotiating regulatory objectives with global health authorities.

• Experience managing regulatory activities in collaborative or partnership-driven development environments.

• Key Competencies

• Strategic Thinking

• Regulatory Leadership

• Health Authority Negotiation

• Cross-Functional Influence

• Risk Assessment & Mitigation

• Submission Planning & Execution

• Stakeholder Management

• Executive Communication

• Global Team Leadership

• Decision Making in Complex Environments

• Industry: Pharmaceuticals / Biotechnology

• Function: Regulatory Affairs

• Therapeutic Area: Cardiovascular

• Employment Type: Contract / Full-Time (as applicable)

• Experience Level: Senior Director / Executive Director equivalent experience preferred for late-stage development leadership roles.

• Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

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Benefits

• Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Everforth Apex team member can provide.

• Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

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• Benefits

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