Manager, 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.

Brief team/department description:

Manager, Regulatory Affairs: Managing EU and International Regulatory activities for assigned projects

Manage the regulatory filings of medicinal products via EU centralized procedure as well as MRP/DCP/NP procedures, including but not limited to MAAs, variations, MATs, and other associated life cycle maintenances submissions. Main role is to be a primary interface with the EMA and maintaining 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:

• Manage and coordinate regulatory submissions for all projects to include but not limited to Scientific Advice, Pediatric Implementation Plan submissions, MAAs, variations and other associated life cycle maintenances submissions.
• Develop and implement regulatory strategies for product registration and life cycle
• Lead cross-functional discussions to align on submission strategies, prioritize activities, and establish realistic implementation timelines for regulatory activities based on the cross-functional requirements.
• Review labelling (SPC, PIL and Labelling) to ensure compliance against current guidelines and standards
• Review change controls for the regulatory team
• Ownership of all outside communication with EU/EEA Health Authorities (EMA, National
• Competent Authorities) on behalf of the Company
• Provide guidance to support with regulatory related questions and complaints
• Monitor evolving regulatory requirements and provide proactive advice to cross functional teams
• Follow company policies and procedures
• Contribute to generate and review SOPs and Work instructions
• 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
• Manage 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
• Managing publishing and translation activities with support from partner CRO
• Support review of EU promotional material

Qualifications and Education Requirements

• Bachelor of Science, Biological Sciences or other related area of study
• 5-7+ years of experience in Regulatory Affairs especially with European, UK exposure
• Regulatory Affairs exposure to China would be considered a plus
• Proven experience with EMA, NCA’s
• Strong background in pre-marketing activities and preparation of MAA’s
• Ability to perform under pressure with limited resources
• Excellent communication and presentation skills in English
• Strong writing analytical and problem-solving abilities

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