Senior Director / Regulatory Affairs Head EU at Azurity Pharmaceuticals

Dublin, County Dublin, Ireland

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Bachelor’s degree in Life Science or other related disciplines with at least 15+ years of Regulatory experience
Thorough understanding of EU Regulatory landscape
Proven experience in leading dynamic teams, fostering a culture of efficiency and teamwork
Demonstrated track record of successful product launches
Excellent organizational, interpersonal, verbal, and written communication skills
A strong network and working rapport with regulatory authorities, agencies and third-party consultants
The ability to adapt to changing environment and circumstances requiring flexibility, empathy and sense of urgency

Responsibilities

Leading, further building and developing the EU RA team
Empowered to develop and lead regulatory strategies to achieve Azurity’s true north goals
Providing EU regulatory strategy and leadership for existing and future portfolio of assets
Advising internal teams and management on regulations, guidance, and industry best practices
Performing regulatory reviews, working with cross-functional leaders to facilitate discussions and evaluate regulatory risks
Overseeing MLR (medical, legal, regulatory) review committee outcomes
Advising on SOP’s and Work Instructions as applicable, to ensure high performing regulatory operations and effective review processes
Coaching and mentoring the team on changing regulatory environment for new regulations, guidance, and enforcement
Recruiting, developing and acting as an advisor and coach to direct reports and junior members of the regulatory team

Skills

EU Regulatory Affairs

Regulatory Strategy

Team Leadership

Pharmaceutical Regulations

Portfolio Management

Cross-functional Collaboration

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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