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Location

Secunderabad | India

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Job description

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 .

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.

Roles And Responsibilities

Role: Develop and implement the effectiveness of the robust regulatory strategy and approach for assigned projects across the product life cycle management stages, ensuring continued regulatory compliance.

Key Accountabilities: Providing regulatory guidance, requirements, and strategy for assigned projects to internal and external stakeholders, ensuring compliance with regulations, company standards and commitments.

Responsibilities

• Represent Regulatory Affairs and assist with regulatory activities for assigned projects including serving as the regulatory liaison with stakeholders.
• Direct interaction and liaison with FDA and other regulatory agencies, as required.
• Review of technical submission documents and provide regulatory feedback to ensure completeness, accuracy, and regulatory compliance.
• Manage regulatory filings (IND, PIND, Pre-NDA, Pre-ANDA, CGT, PFC, iPSP, Controlled Correspondences, NDA, ANDA etc.), including authoring scientific briefing book packages and eCTD sections in accordance with regulatory guidelines, applicable federal laws, and statutory requirements.
• Manage operational aspects of preparing compliant submissions to regulatory agencies.
• Establish and manage timelines associated with regulatory submissions in alignment with business priorities.
• Manage and address deficiencies (IR, DRL and CRL) received from FDA within pre-defined timelines, with adequacy and accuracy in consultation with stakeholders.
• Responsible for managing and tracking regulatory-related changes.
• Responsible for evaluating post approval change controls as per the regulatory agency guidelines to determine the appropriate reporting category and explicitly defining the necessary conditions and documents needed to implement the change.
• Manage archival of regulatory submissions, contact reports and correspondence logs.
• Provide regulatory guidance on requirements for development projects and post-approval changes as required for assigned projects.
• Keep abreast of current regulations and regulatory guidance, assessing impact to assigned projects and internal processes.
• Participate in various activities of setting goals, tracking deliverables, and process improvements within the regulatory department.
• Develop collaborative and respectful relationships with internal and external partners, ensuring activities are performed according to regulatory strategies and assisting with regulatory questions.

Qualifications and Education Requirements

• Master of Pharmacy (M. Pharm): Minimum of 8 years of pharmaceutical industry experience; minimum of 5 years of regulatory experience with extensive knowledge and experience of US regulatory affairs.
• Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing skills, and MS Office skills are required.
• Track record of successfully working with cross-functional teams, including external partners
• Ability to work independently with minimal supervision in a fast-paced deadline driven environment .
• Keen attention to detail.
• Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and regulatory requirements are met .

Physical & Mental Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Must be able to sit for long periods of time
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
• May occasionally climb stairs and/or ride elevators
• The employee must occasionally lift and/or move up to 25 pounds
• Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
• Other miscellaneous job duties as required

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Job tags

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Salary