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Vice President of Regulatory Affairs

2 months ago

Atlanta, Georgia, United States augmentjobs Full time
Job Overview

Position Title: Vice President of Regulatory Affairs

Company: Augmentjobs

Compensation Range: $160,000 - $270,000

Experience Level: 12-15 years

Role Summary:

As the Vice President of Regulatory Affairs at Augmentjobs, you will play a pivotal role in steering and supervising all regulatory operations within the organization. Your responsibilities will encompass the formulation and execution of regulatory strategies to guarantee adherence to all relevant laws and regulations while advancing the company's strategic objectives. You will collaborate closely with various divisions, including Research & Development, manufacturing, and legal, to ensure the successful approval and market introduction of new products and services.

Key Responsibilities:
  • Regulatory Strategy Formulation:
    • Design and implement thorough regulatory strategies for both new and existing products, ensuring they align with corporate goals and regulatory mandates.
    • Offer strategic counsel on regulatory matters to senior leadership and other essential stakeholders.
  • Regulatory Compliance Oversight:
    • Manage and ensure compliance with federal, state, and international regulations pertinent to the company's offerings.
    • Keep abreast of regulatory changes and evaluate their implications for the company's operations.
  • Regulatory Documentation and Approvals:
    • Oversee the preparation, submission, and management of regulatory documents, including applications for new products, amendments, and renewals.
    • Engage with regulatory bodies to facilitate prompt approvals and resolve any inquiries or issues.
  • Leadership and Team Development:
    • Build, guide, and mentor a high-performing regulatory affairs team.
    • Foster a culture of continuous improvement and professional growth within the team.
  • Cross-Departmental Collaboration:
    • Work in tandem with R&D, manufacturing, quality assurance, and legal teams to ensure regulatory considerations are embedded in product development and business processes.
    • Represent the regulatory affairs function in cross-departmental project teams and strategic discussions.
  • Risk Management:
    • Identify and mitigate regulatory risks associated with the company's products and operations.
    • Develop and implement contingency strategies to address potential regulatory challenges.
  • Stakeholder Relationship Management:
    • Establish and nurture strong relationships with regulatory agencies and industry organizations.
    • Participate in industry discussions and contribute to dialogues on regulatory policies and practices.
Qualifications:
  • Education:
    • Bachelor's degree in Life Sciences, Engineering, or a related discipline (required).
    • Advanced degree (Master's or PhD) or professional certification (e.g., RAC) preferred.
  • Experience:
    • 12-15 years of experience in regulatory affairs, with a substantial portion in a leadership or senior management capacity.
    • Demonstrated success in managing regulatory submissions and interactions with regulatory authorities.
  • Technical Expertise:
    • In-depth knowledge of regulatory requirements and guidelines in the relevant sector (e.g., pharmaceuticals, medical devices, biotechnology).
    • Strong understanding of regulatory processes and standards in key markets, including the FDA, EMA, and other international regulatory bodies.
  • Leadership Abilities:
    • Proven capability to lead and develop a team, with strong coaching and mentoring skills.
    • Excellent strategic thinking and problem-solving capabilities.
  • Communication Skills:
    • Outstanding written and verbal communication skills, with the ability to effectively convey complex regulatory information to diverse audiences.
    • Proven ability to negotiate and influence outcomes with regulatory agencies and internal stakeholders.
  • Organizational Skills:
    • Strong project management abilities with the capacity to manage multiple priorities and deadlines.
    • Attention to detail and a commitment to delivering high-quality work.
Working Environment:
  • This position is based at Augmentjobs' headquarters with occasional travel required for meetings with regulatory agencies and industry events.
  • Flexibility in working hours may be necessary to accommodate international regulatory requirements and deadlines.
Application Instructions:

Interested candidates should submit their resume and a cover letter outlining their qualifications and experience relative to the job description.

This overview provides a detailed understanding of the Vice President of Regulatory Affairs position, ensuring that candidates are well-informed about the responsibilities, skills, and qualifications necessary for the role.