Senior Regulatory Affairs Manager - Hybrid, Submissions

Regulatory Toolkit; Woburn (MA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Azurity Pharmaceuticals is seeking a Regulatory Affairs Manager to oversee regulatory activities for assigned products and serve as the regulatory representative on cross-functional teams. Responsibilities include authoring HA submissions for US and Canada and ensuring compliance with evolving regulations across North America.

The role requires directing regulatory strategies for drug product registration and lifecycle management, managing submissions (IND/NDA/ANDA) across multiple dosage forms,

Qualifications

• Minimum Bachelor of Science or advanced health care discipline degree or equivalent.
• Minimum of 10 years in the pharmaceutical industry with at least 8 years in regulatory affairs.
• Experience working with cross-functional teams and external partners.
• Strong written and verbal communication skills; proficient in MS Office.

Responsibilities

• Represent Regulatory Affairs on cross-functional teams for assigned products/projects.
• Provide regulatory guidance and determine requirements/strategy for submissions.
• Prepare Health Authority submissions for US and Canada and manage regulatory filings (IND, NDA, ANDA, NDS, DMF).
• Monitor regulatory changes and advise teams to ensure compliance.

Skills

Regulatory affairs

Project management

FDA liaison

Cross-functional collaboration

Regulatory strategy

Education

Advanced health care degree (PharmD/PhD/MS)

Tools

MS Office

Job description

Azurity Pharmaceuticals is seeking a Regulatory Affairs Manager to oversee regulatory activities for assigned products and serve as the regulatory representative on cross-functional teams. Responsibilities include authoring HA submissions for US and Canada and ensuring compliance with evolving regulations across North America.

The role requires directing regulatory strategies for drug product registration and lifecycle management, managing submissions (IND/NDA/ANDA) across multiple dosage forms,