Senior Associate, Regulatory Affairs

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Senior Associate, Regulatory Affairs : Supporting EU and International Regulatory activities for assigned projects

Preparation and coordination of the regulatory filings medicinal products via EU centralized procedure as well as MRP / DCP procedures, including but not limited to MAAs, variations, MATs, and other associated life cycle maintenances submissions. Support with EMA / NCA communications and support the team ensuring good working relationship with Product Leads, Rapporteurs, CHMP members and other EMA officials to secure timely approval of filings. Support in International territories in Life cycle maintenance.

Principle Responsibilities

• Preparation and coordination of the regulatory documentation for Regulatory Affairs & Scientific Advice procedures, Response to Questions, Pediatric Implementation Plan submissions and related activities in Europe
• Support change control assessments for EU / International
• Periodically reviewing the product information (SPC, PIL and Labelling) for compliance against the Core Safety Information (CSI) as well as current EU guidelines and standards
• Support the artwork preparation and approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs, or changes to existing packaging
• Communication with relevant internal and external suppliers / departments and assistance with implementation being achieved effectively and on time
• Contribute to generate and review SOPs and Work instructions
• Review labelling (SPC, PIL and Labelling) to ensure compliance against current guidelines and standards
• Monitor evolving regulatory requirements and provide proactive advice to cross-functional teams.

Qualifications And Education Requirements

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.

Skills Required

Regulatory Affairs