Associate Director, Regulatory Affairs

Job Description

Job Description

A pioneering biopharmaceutical company is seeking an Associate Director, Regulatory Affairs to lead global clinical trial application (CTA) strategy and regulatory compliance efforts. This organization is leveraging revolutionary technology at the intersection of chemistry, engineering, computation, and biology to unlock novel drug targets.

Key Responsibilities:

• Develop and execute global CTA submission strategies across Europe, LATAM, APAC, and ROW
• Ensure compliance with evolving ex-US regulations (EU-CTR, ICH, country-specific)
• Collaborate cross-functionally with Clinical Operations, CMC, Supply Chain, and more
• Liaise with global regulatory agencies and manage submission platforms (CTIS, IRIS)
• Oversee regulatory aspects of GCP, GDPR, and quality systems
• Identify and mitigate regulatory risks across programs

Qualifications:

• 8+ years in Regulatory Affairs with global CTA experience
• Strong knowledge of international regulatory frameworks and submission platforms
• Excellent communication, project management, and cross-functional collaboration skills
• Comfortable in a fast-paced, high-growth biotech environment

A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.
Job Responsibilities:
•\tConducting Post Market Activities and Post Market Surveillance
•\tManaging Customer and Product Complaint Investigation programs
Education and Experience:
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry
•\tBachelor's degree
•\tComputer proficiency

Company Description

A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.\r\nJob Responsibilities:\r\n•\tConducting Post Market Activities and Post Market Surveillance\r\n•\tManaging Customer and Product Complaint Investigation programs\r\nEducation and Experience:\r\n•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry\r\n•\tBachelor's degree\r\n•\tComputer proficiency