Company: Augmentjobs
Salary Range: $120,000 - $170,000
Experience Level: 8 - 10 years
The Director of Regulatory Affairs at Augmentjobs will be responsible for overseeing the development and implementation of regulatory strategies, ensuring compliance with all applicable regulations, and managing relationships with regulatory agencies. This role is critical in safeguarding the company's operations and ensuring that all products and services meet regulatory standards.
Key Responsibilities:Regulatory Strategy: Develop and implement comprehensive regulatory strategies for the company's products and services. Ensure alignment with both domestic and international regulatory requirements.
Compliance Management: Monitor and ensure compliance with all relevant regulations, guidelines, and standards. Identify regulatory risks and implement mitigation strategies.
Regulatory Submissions: Oversee the preparation and submission of regulatory documents, including product registrations, licensing, and approvals. Ensure accuracy and timely submission of all regulatory filings.
Agency Liaison: Serve as the primary point of contact with regulatory agencies. Build and maintain positive relationships with key regulatory stakeholders.
Cross-functional Collaboration: Work closely with internal teams, including R&D, legal, quality assurance, and marketing, to ensure regulatory requirements are met throughout the product lifecycle.
Regulatory Intelligence: Stay informed about industry trends, regulatory changes, and emerging issues. Provide guidance and updates to senior management on relevant regulatory developments.
Training and Development: Provide regulatory training and guidance to internal teams. Develop and implement training programs to ensure staff understand regulatory requirements and compliance procedures.
Audit and Inspection: Prepare for and manage regulatory audits and inspections. Address findings and implement corrective actions as needed.
Reporting: Prepare and present regulatory affairs reports to senior management and stakeholders. Track and report on regulatory performance and compliance metrics.
Education: Bachelor's degree in a relevant field (e.g., Law, Life Sciences, Engineering). Advanced degree (e.g., Master's or Ph.D.) is preferred.
Experience: 8-10 years of experience in regulatory affairs, with at least 5 years in a leadership role. Experience in the [specific industry or field relevant to the company's products/services] is highly desirable.
Regulatory Knowledge: In-depth knowledge of regulatory requirements, guidelines, and standards applicable to the industry. Familiarity with both domestic and international regulations.
Leadership: Proven ability to lead and manage a team of regulatory professionals. Strong leadership and interpersonal skills.
Analytical Skills: Excellent analytical and problem-solving skills. Ability to interpret complex regulations and provide strategic recommendations.
Communication: Strong verbal and written communication skills. Ability to effectively communicate regulatory concepts to both technical and non-technical audiences.
Project Management: Proven ability to manage multiple projects simultaneously and meet deadlines. Strong organizational and time management skills.
Attention to Detail: High level of accuracy and attention to detail in all aspects of regulatory affairs.
Adaptability: Ability to adapt to changing regulations and industry standards. Flexible and open to new challenges.
Travel: Some travel may be required for regulatory meetings and inspections.
Augmentjobs is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
To apply: Submit your resume and cover letter detailing your experience and qualifications for this role.
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