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 www.azurity.com.
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.
If you are looking to be a part of a dynamic, global, fast-growing organization, have a positive attitude, willing to develop yourself, and are energized by being a part of improving the health of others, we are the perfect match for you. By joining us as the
Global Head of Regulatory Affairs your position will be broad, communication between departments will be fast and effective and you will have significant responsibility and autonomy for your work and contributions.
As the Global Head of Regulatory Affairs working on the Global Regulatory Affairs team you will be empowered to develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and multiple projects.
Principle Responsibilities:
- Oversees regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan. Provides strategic and tactical advice and guidance to allow the timely and efficient conduct of all regulatory projects. Ensures compliance for global regulatory requirements.
- Is a leader, contributing to cross-functional initiatives and influencing as applicable and demonstrating leadership behaviors.
- Directs and oversees multiple projects (inclusive of highly complex ones), generally has global/regional oversight for assigned products, this includes oversight to ensure regulatory compliance (e.g. on registration database) by staff and / or vendor.
- Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility. Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications.
- Provides leadership and development for direct reports, including those that serve as regional regulatory leads responsible for the design and execution of regional regulatory strategies.
- Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
- Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
- Accountable for all global submissions and approvals of project(s) and/or oversees direct reports responsible.
- Oversees all submissions.
- Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; or delegates and oversees direct reports and / or vendor; negotiates on behalf of RA team, as necessary.
- Accountable for working with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions are provided in compliance with local regulations. And to maintain compliance for products.
- Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
- Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
Qualifications and Education Requirements:
- MD, PhD or PharmD in a scientific discipline preferred along with 15+ years of experience in Regulatory Affairs
- Proven success in regulatory submissions.
- FDA, EU, Canada, ROW, and post-marketing experience is a plus with sound knowledge of such principles as GxP's, FDA, and EU guidelines.
- Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
- Experience with investigational drugs, including late stage development, and marketed products
- CRO management experience preferred.
- Prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals, is highly desirable
- Must be a strong leader that creates a vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff.
- Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Strategic thinker, planner, and implementer with excellent organizational skills.
- Excellent oral and written communication skills and knows how to present data/issues both to a technical and non-technical audience with the ability to write and edit regulatory documents.
- Able to plan and execute regulatory projects, and proven record of delivering results within business-defined timeframes.
- Proven ability to work on complex problems where analysis of the situation or data requires an evaluation of intangible variables.
- Demonstrates potential for a high level of collaboration with others and within global teams.
- Independent thought, negotiation skills, integrity, and adaptability.
- Ability to work on own and in virtual setting.
- MS Office skills with excellent use of excel, PowerPoint and MS Project required.
- Recent experience with a smaller entrepreneurial environment is a definite asset.
- Fluent in English (written and oral).
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
Benefits We Offer: - Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
- Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
- Fuel Your Success: *Sales Only* - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.
- Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
- Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. *Excludes Sales, Manufacturing, and some Operations positions*
- Start Your Week on a High Note: Indulge in our “Bagel Tuesday” perk, where you can enjoy a fresh bagel on us every Tuesday morning. **Only for On-site/Hybrid colleagues**
- Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
- Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
- Meaningful Time with Your Loved Ones: We close between Christmas and New Year’s to give you an extra week off to spend quality time with your family and recharge.
- Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
- Summer Vibes: Embrace the summer season with our Summer-Hours perk, available between Memorial Day and Labor Day. **Excludes Sales Colleagues**
- Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
- Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.
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