Director, Regulatory Affairs – Clinical Strategy at Azurity Pharmaceuticals

Woburn, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

In-depth knowledge of regulatory and clinical information analysis for developing complex strategies supporting drug products
Expertise in FDA and other health authority clinical and regulatory requirements for investigational and approved marketing applications
Ability to provide clinical strategic support for due diligence activities
Strong cross-functional collaboration skills with teams including Franchise Managers, Clinical Development, Medical Affairs, and Product Development
Knowledge and understanding of integrated data from clinical trials, including efficacy, safety, pharmacovigilance, and clinical pharmacokinetics
Experience participating/leading FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings
Mentoring, development, and coaching skills for regulatory team members on clinical strategy and writing

Responsibilities

Development and implementation of clinical regulatory strategies and tactics, including Modeling Informed Drug Development (MIDD), real-world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets, considering FDA and other health authority requirements
Provide critical evaluation and review of clinical documents to support regulatory objectives; proactively identify risks and develop/implement mitigation strategies
Interact with and support Clinical Development and Medical Affairs teams to review clinical protocols and other documents; provide regulatory clinical strategic input
Preparation and presentation of research data and findings on clinical/regulatory strategy to Azurity Executive and Senior Leadership for alignment
Authoring, preparation, and/or review of relevant clinical sections of regulatory applications such as INDs, NDAs, BLAs, including ISS and ISE, initial pediatric study plans, waivers, clinical and non-clinical sections
Assessment of regulatory and critical clinical approval factors including PK, PREA, and other post-marketing safety studies
Evaluation and determination of regulatory pathways within relevant therapeutic areas to provide insight into potential development opportunities for the Azurity R&D pipeline

Skills

Key technologies and capabilities for this role

Regulatory AffairsClinical StrategyDrug DevelopmentHealth Authority RequirementsIND/NDA ApplicationsDue DiligenceCross-functional Collaboration

Questions & Answers

Common questions about this position

What is the salary for the Director, Regulatory Affairs – Clinical Strategy position?

This information is not specified in the job description.

Is this role remote or does it require office presence?

This information is not specified in the job description.

What key skills are required for this role?

The role requires expertise in developing clinical regulatory strategies including Modeling Informed Drug Development (MIDD), real-world data (RWD)/real-world evidence (RWE), and meta-analysis, along with knowledge of FDA and other health authority requirements, clinical document review, and cross-functional collaboration.

What is the company culture like at Azurity Pharmaceuticals?

Azurity is an inclusive workplace and Equal Opportunity Employer with a talented, dedicated team focused on benefiting patients through the best science and commitment to quality, seeking individuals with dedication, integrity, and creative spirit.

Who does this position report to and what teams will it work with?

The position reports to the Senior Director, Head of Regulatory Affairs and works cross-functionally with teams including Franchise Managers, Clinical Development, Medical Affairs, and Product Development.

Azurity Pharmaceuticals

Develops specialized formulations of medicines

About Azurity Pharmaceuticals

Azurity Pharmaceuticals develops specialized formulations of existing medicines to meet the needs of patients who are often overlooked by traditional pharmaceutical companies. Their products include oral suspensions and other forms that are easier to administer, particularly for those who have difficulty swallowing pills or need precise dosing. This focus on creating accessible and effective medications enhances patient compliance and addresses gaps in the pharmaceutical market. Azurity serves healthcare providers, hospitals, and pharmacies, generating revenue through the sale of FDA-approved proprietary medicines across various therapeutic areas, including cardiovascular, central nervous system, and oncology. Their goal is to improve patient outcomes by providing high-quality, innovative medicines tailored to specific medical conditions.

Woburn, MassachusettsHeadquarters

2000Year Founded

$182.2MTotal Funding

GROWTH_EQUITY_VCCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Company Match

401(k) Retirement Plan

Paid Vacation

Paid Holidays

Hybrid Work Options

Professional Development Budget

Tuition Reimbursement

Wellness Program

Risks

Product recalls, like Zenzedi's, can damage brand reputation and cause financial losses.

Integration challenges from Slayback Pharma acquisition may disrupt operations.

Reliance on FDA approvals means regulatory delays could impact product launches.

Differentiation

Azurity focuses on innovative dose forms for overlooked patient needs.

Their FDA-approved products ensure safety and efficacy in specialized formulations.

Azurity's acquisition of Slayback Pharma enhances its development and launch capabilities.

Upsides

Growing demand for personalized medicine aligns with Azurity's specialized dose forms.

Increasing chronic diseases boost need for Azurity's innovative drug delivery systems.

FDA's focus on novel formulations benefits Azurity's product pipeline.

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