Regulatory Affairs Manager/Senior Manager

Job Description
This role supports regulatory strategy implementation for development programs and ensures compliance with relevant regulations and internal standards. It involves managing assigned projects, overseeing submissions to regulatory agencies, and collaborating with cross-functional teams to achieve organizational goals.

Responsibilities:

• Compile and submit safety reports and other required documents for clinical studies.
• Maintain a database of regulatory interactions, including questions and responses from regulatory agencies.
• Create and update summary sheets for relevant products and maintain documentation templates to align with current guidelines.
• Provide input on regulatory strategy documents and assist in preparing targeted product profiles.
• Stay current with regulatory laws, regulations, and policies relevant to the industry.
• Manage aspects of development projects and collaborate with teams to draft agency meeting requests and briefing materials.
• Act as a liaison for routine correspondence with regulatory agencies and oversee annual reporting requirements.
• Participate in project team meetings and track applications through the review process.

Qualifications:

• Bachelor’s degree in a related field (e.g., pharmacy, biology, chemistry, pharmacology). An advanced degree or certifications are a plus.
• Minimum of 2 years of regulatory or industry-related experience, with pharmaceutical R&D exposure preferred.
• Knowledge of regulatory guidelines and policies.
• Strong organizational skills, attention to detail, and the ability to meet deadlines.
• Excellent verbal and written communication skills.
• Experience leading projects and interacting with regulatory agencies is desirable.
• Global regulatory experience is an advantage.