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:
Team is responsible for designing and executing global regulatory strategies to ensure the timely approval of a diverse portfolio of pharmaceutical products and the lifecycle maintenance of these products. The team works across multiple complex projects, facilitating various types of submissions to agencies like the FDA, EMA, MHRA or EU National Authorities, HC, and other international authorities, by ensuring compliance with evolving regulations.
PRINCIPLE RESPONSIBILITIES:
- Drive end-to-end regulatory strategies for product registration and approval across US, EU, UK, Canada markets by managing the submissions including Pre-INDs, Scientific Advice (ScAs), Pediatric Investigation Plans (PIPs), and Notified Body Opinions etc.
- Oversee the end-to-end preparation, review, and filing of regulatory dossiers (NDAs, NDSs, and MAAs (CP, DCP, MRP, NPs) etc. to ensure timely submissions.
- Lead cross-functional team discussions to align submission strategies, define priorities, and establish realistic timelines based on evolving regulatory requirements.
- Perform global regulatory due diligence and comprehensive gap assessments to identify potential risks and mitigation strategies for US, EU, UK, and Canada filings.
- Manage the review and approval of artwork, including SPCs and PILs, ensuring adherence to current standards.
- Manage regulatory readiness for launch in compliance with evolving EU and UK regulations.
- Hands on experience in handling activities related to xEVMPD, RIMS, PLM, IRIS, etc.
- Support the assessment of promotional materials to ensure regulatory compliance, as needed.
- Direct post-approval regulatory activities, including supplements, variations, and renewals, to ensure continuous compliance throughout the product lifecycle, as needed.
- Monitor evolving, region-specific regulations and proactively provide strategic guidance to cross-functional teams to ensure compliance
CORE RESPONSIBILITIES:
- Lead the development and execution of end-to-end regulatory strategies for pharmaceutical products across the US, EU, UK, Canada markets.
- Ensuring successful submissions including Pre-INDs, ScAs, NDAs, NDSs, and MAAs (CPs, DCPs, MRPs, NPs) etc.
- Manage Health Authority (FDA, EMA, MHRA or National Authorities, HC) communications and secure timely/required feedback and approvals.
- Provide regulatory support for international territories, ensuring compliance and continuity in lifecycle maintenance.
- Oversee lifecycle management activities, including supplements, variations, and other post-approval regulatory submissions on need basis.
Qualifications and Education Requirements
- 8+ years of experience in pharmaceutical regulatory affairs for US, EU, UK, Canada markets
- Master of Science in Pharmaceuticals or Equivalent
- Regulatory Affairs exposure to China and Emerging markets would be considered a plus
- Ability to perform under pressure with limited resources
- Excellent communication and presentation skills in English
- Strong writing analytical and problem-solving abilities
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.
