Azurity Pharmaceuticals

Reformulates established medicines into alternative doses

Deputy Manager/Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeHyderabad, Telangana, IndiaNo salary listedIn-person

About the Job

Requirements

At least 8 years of experience in pharmaceutical regulatory affairs for the US, EU, UK, and Canada markets.
A Master of Science in Pharmaceuticals or equivalent.
Ability to perform under pressure with limited resources.
Excellent communication and presentation skills in English.
Strong writing, analytical, and problem-solving abilities.

Responsibilities

Drive end-to-end regulatory strategies for product registration and approval across the US, EU, UK, and Canada by managing submissions, including Pre-INDs, Scientific Advice (ScAs), Pediatric Investigation Plans (PIPs), and Notified Body Opinions.
Oversee the end-to-end preparation, review, and filing of regulatory dossiers, including NDAs, NDSs, and MAAs (CP, DCP, MRP, and NPs), 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.
Handle activities related to xEVMPD, RIMS, PLM, and IRIS.
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.
Lead the development and execution of end-to-end regulatory strategies for pharmaceutical products across the US, EU, UK, and Canada markets.
Ensure successful submissions, including Pre-INDs, ScAs, NDAs, NDSs, and MAAs (CPs, DCPs, MRPs, and NPs).
Manage Health Authority communications with the FDA, EMA, MHRA, National Authorities, and HC, and secure timely and 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, as needed.

Desired Qualifications

Regulatory affairs exposure to China and emerging markets.

At Azurity, we're redefining medicine for the real world. Most medicines are designed for how they're approved; ours are built for real life. That shift drives everything we do. We challenge the status quo — repurposing proven molecules with intention, reimagininghow therapies are designed, delivered, and accessed so they work in the realities of everyday life. And with a diversified and growing portfolio, we bring the agility, scale, and global reach to deliver meaningful solutions to patients, providers, and healthcare systems around the world. Because medicine should fit into life, not force life to fit around it. With more than 70 medicines across 11 therapeutic areas, Azurity’s mission is fueled by a growing portfolio that reaches millions of people in more than 50 countries. Learn more at www.azurity.com and LinkedIn.

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.

About the Company

Azurity Pharmaceuticals

Reformulates established medicines into alternative doses

Azurity Pharmaceuticals focuses on developing specialized dose forms of existing medicines to meet unmet patient needs in the U.S., especially for those who have difficulty swallowing or require precise dosing. It creates formulations like oral suspensions across therapeutic areas including cardiovascular, CNS, endocrine, GI, anti-infective, and oncology, marketed to providers, hospitals, and pharmacies. Unlike firms that launch new chemical entities, Azurity expands access by reformulating approved drugs into tailored, regulatory-compliant products such as FIRVANQ, HORIZANT, GLIADEL Wafer, SOTYLIZE, VIVIMUSTA, and others. Its goal is to improve patient outcomes by making FDA-approved medicines easier to use and accessible for overlooked patient populations.

Company size: 201-500
Company stage: Growth Equity (Venture Capital)
Total funding: $182.2M
Headquarters: Woburn, MA
Founded: 2000

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