Full-Time
Director – Regulatory Affairs
Confirmed live in the last 24 hours
Azurity Pharmaceuticals
201-500 employees
Develops specialized formulations of medicines
Expert
Burlington, MA, USA
- Bachelor’s degree in Life Science or other related discipline.
- At least 10 years’ experience in Regulatory Affairs, with direct experience in Labeling and Advertising/Promotional review.
- Experience leading team members, fostering a culture of efficiency and teamwork.
- Demonstrated track record of successful product launches.
- Strong expertise and knowledge of Advertising/Promotional regulations and guidance.
- Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading skills.
- Responsible for providing commercial regulatory strategy and leadership for promotional materials.
- Advise internal teams and management on regulations, guidance, and industry best practices related to product labeling and advertising/promotional components.
- Perform regulatory review of advertising and promotional materials, as required.
- Lead cross-functional teams to facilitate discussions regarding regulatory labeling submission strategies, required documentation and regulatory risks.
- Lead the MLR (medical, legal, regulatory) review committee for advertising and promotional components.
- Knowledge of submission process for promotional components to FDA's Office of Prescription Drug Promotion (OPDP).
- Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing skills, and MS Office skills are required.
- Knowledge of pharmaceutical labeling, packaging components, graphic arts capabilities (ADOBE® Illustrator/XML), and SPL labeling process.
- Track record of successfully working with third-party vendors.
- Create/revise SOP’s and Work Instructions as applicable, to ensure high performing regulatory operations and effective review processes.
- Continuously monitor the regulatory environment for new regulations, guidance, and enforcement.
- Recruit, develop and act as an advisor and coach to direct reports and junior members of the regulatory team.
- 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.
Azurity Pharmaceuticals develops specialized formulations of existing medicines to meet the needs of patients who are often overlooked by other 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 commitment to quality and innovation has led to the development of numerous products that significantly benefit patients, positioning Azurity as a key player in the specialized pharmaceutical sector.
Company Stage
Series B
Total Funding
$182.2M
Headquarters
Woburn, Massachusetts
Founded
2000
Simplify's Take
What believers are saying
- FDA approval of Myhibbin™ highlights Azurity's capability to bring unique, patient-centric formulations to market, potentially increasing their market share.
- The acquisition of Slayback Pharma and Arbor Pharmaceuticals expands Azurity's development portfolio, promising a significant number of new medicine launches and enhancing their market position.
- Azurity's focus on underserved patient segments and innovative dose forms can lead to high patient satisfaction and loyalty, driving long-term growth.
What critics are saying
- Product recalls, such as the recent Zenzedi recall, can damage Azurity's reputation and lead to financial losses.
- The specialized nature of their products may limit their market size, making them vulnerable to market fluctuations and competitive pressures.
What makes Azurity Pharmaceuticals unique
- Azurity Pharmaceuticals focuses on developing innovative dose forms of established medicines, addressing unmet needs in the healthcare market, unlike competitors who may focus solely on new drug development.
- Their commitment to creating easier-to-administer formulations, such as oral suspensions, sets them apart by enhancing patient compliance and filling gaps in the pharmaceutical market.
- Azurity's broad therapeutic portfolio and FDA-approved proprietary products ensure they meet stringent regulatory standards, providing a competitive edge in quality and safety.