Associate Director, Regulatory Affairs – Clinical Trials, FSP Strategy & Business Development

This is a fully remote position, open to applicants in Portugal.

📋 Description

• Ensure adherence to global regulations.

• Analyze and communicate global regulations, guidelines, and new industry trends.

• Collaborate with cross-functional teams to launch innovative products.

• Assist in the development and execution of regulatory strategies.

• Uphold compliance throughout the entire product lifecycle.

• Aid in the continuous enhancement of regulatory tools and information systems.

• Make a significant impact by promoting patient safety while facilitating business growth through effective regulatory compliance.

⛳️ Requirements

• Advanced Degree with 6 years of regulatory affairs experience, or a Bachelor's Degree with 8 years of regulatory affairs experience.

• Preferred fields of study: science, engineering, pharmacy, or a related discipline.

• Comprehensive understanding of global regulatory requirements and frameworks, especially concerning emerging technologies.

• Proven history of successful regulatory submissions and filings with global authorities.

• Exceptional ability to assess regulatory impacts on products and provide strategic guidance.

• Experience in managing and enhancing regulatory information systems (RIMS).

• Excellent communication and presentation skills for articulating complex regulatory concepts.

• Advanced project management skills to oversee multiple complex initiatives.

• Proven ability to collaborate and engage effectively with key stakeholders.

• Experience in working with regulatory authorities, trade associations, and professional organizations.

• Proficient in regulatory software tools and systems.

• Capability to develop regulatory policies and guidelines.

• Experience in post-market surveillance and vigilance activities.

• Strong skills in cross-functional collaboration.

• Ability to work efficiently in a global environment.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Paid time off.

• Flexible work arrangements.

• Professional development opportunities.