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

• Ensure adherence to global regulatory standards.

• Analyze and communicate global regulations, guidelines, and emerging trends in the industry.

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

• Assist in the creation and execution of regulatory strategies.

• Sustain compliance throughout the entire product lifecycle.

• Promote ongoing enhancement of regulatory tools and information systems.

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

• Preferred academic backgrounds include science, engineering, pharmacy, or related fields.

• Extensive knowledge of global regulatory requirements and frameworks, especially concerning emerging technologies.

• Proven experience in regulatory submissions and filings with international authorities.

• Strong capability to assess the regulatory impact on products and provide strategic advice.

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

• Exceptional communication and presentation skills to explain complex regulatory concepts.

• Advanced project management skills to oversee multiple intricate initiatives.

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

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

• Proficiency in using regulatory software tools and systems.

• Ability to formulate 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 setting.

• Accessibility/Disability Access.

• Equal Opportunity Employer.

• Health insurance provisions.

• Opportunities for professional development.

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

People also viewed