Senior Director / Regulatory Affairs Head EU at Azurity Pharmaceuticals

Zug, Zug, Switzerland

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Highly motivated with dedication, integrity, and creative spirit
Positive attitude, willing to develop yourself
Energized by improving health of others
Ability to thrive in a dynamic, global, fast-growing organization
Strong leadership behaviors, contributing to cross-functional initiatives and influencing as applicable
Ability to anticipate risks, develop solutions, and discuss with team and management
Understanding of probabilities of technical success for solutions
Sound judgement in communicating professionally and timely with project teams, line management, and stakeholders

Responsibilities

Oversee regional regulatory leads and staff to ensure global/regional regulatory strategies are written, reviewed, and executed according to plan
Provide strategic and tactical advice and guidance for timely and efficient conduct of all regulatory projects
Ensure compliance for global regulatory requirements
Direct and oversee multiple projects (including highly complex ones) with global/regional oversight for assigned products, ensuring regulatory compliance (e.g., on registration database) by staff and/or vendors
Oversee and ensure regulatory submissions and approvals are achieved on schedule within area of responsibility; partner with access functions to support access applications
Provide leadership and development for direct reports, including regional regulatory leads responsible for design and execution of regional regulatory strategies
Apprise project team colleagues, line management, and key stakeholders of developments impacting regulatory success
Accountable for all global submissions and approvals of project(s) and/or oversee direct reports responsible
Oversee all submissions
Lead and manage meetings and/or interactions with regulatory authorities and agency meetings; delegate and oversee direct reports and/or vendors; negotiate on behalf of RA team as necessary
Work with other RA functions and/or vendors to ensure regulatory submissions and approvals are achieved on schedule

Skills

Key technologies and capabilities for this role

Regulatory AffairsGlobal Regulatory StrategyEU Regulatory AffairsEMARegulatory SubmissionsCross-functional LeadershipPharmaceutical Regulations

Questions & Answers

Common questions about this position

What is the salary for the Senior Director / Regulatory Affairs Head EU position?

This information is not specified in the job description.

Is this a remote position or what is the location requirement?

This information is not specified in the job description.

What skills and experience are required for this role?

The role requires expertise in developing and leading global regulatory strategies, overseeing regional regulatory leads and staff, providing strategic guidance on regulatory projects, ensuring compliance with global requirements, and managing complex regulatory submissions and approvals.

What is the company culture like at Azurity Pharmaceuticals?

Azurity is a dynamic, global, fast-growing organization that values highly motivated individuals with dedication, integrity, creative spirit, and a positive attitude focused on improving patient health through best science and quality commitment.

What makes a strong candidate for the Global Head of Regulatory Affairs role?

Strong candidates are highly motivated leaders with dedication, integrity, creative spirit, and the ability to thrive in a dynamic environment, demonstrating leadership in cross-functional initiatives and managing complex global regulatory projects with significant autonomy.

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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