Sr. Director, Biotherapies Regulatory Affairs at Vitalant in Scottsdale, Arizona

Job Description:

Description

At Vitalant, we believe in the power of connection and the life-saving impact of blood and biotherapies. As one of the nation's oldest and largest nonprofit transfusion medicine organizations, our mission is to connect people and save lives. Through innovation and collaboration, we're leading the way in biotherapies that extend beyond blood transfusion, paving the path for new treatments and therapies that bring hope to patients in need.

Vitalant is seeking a dynamic Sr. Director, Biotherapies Regulatory Affairs to play a pivotal role in shaping the future of biotherapies at a regional and global level. In this role, you will be the strategic force behind regulatory initiatives that support the development, collection, processing, and laboratory services of life-saving biotherapies. Your leadership will guide cross-functional teams, executive leadership, and external partners in ensuring regulatory excellence, compliance, and innovation in the biotherapies field.

As a key member of our team, you'll drive regulatory strategies that are aligned with our mission to save lives, ensuring that every aspect of our biotherapy processes meets the highest standards of safety and effectiveness. You will not only ensure compliance but also be a vital contributor to shaping the future of the biotherapy industry by representing Vitalant in key industry groups and offering strategic insights that guide the future of biotherapy services.

DUTIES AND RESPONSIBILITIES:

• Provides excellent leadership, communication, and interpersonal skills with the ability to influence and collaborate effectively to achieve high levels of service and product quality, and other criteria in accordance with policies, goals, and objectives.


• Develops and executes regional regulatory strategies to support the development, registration, and commercialization of advanced biotherapy products within specific regions to advance biotherapy and laboratory services.


• Collaborates with cross-functional teams including manufacturers, research & development, clinical, collections, and commercial functions to ensure regulatory compliance and alignment of regulatory activities and development. Align strategies with company objectives


• Oversees, prepares, and submits regulatory documents, applications and licensures to regulatory agencies that governs Biotherapies operations and compliance.


• Foster relationships within industry and regional regulatory authorities, including the FDA to facilitate communication, negotiations, and interactions related to policy, practice standardization, regulatory submission, and approvals to develop appropriate guidance including product registration.


• Monitors regulatory development, changes, and identifies trends while assessing impact on product development and provides strategic guidance to the executive management team to align with company goals and objectives.


• Provides regulatory guidance and support for post-marketing activities, including variations, renewals, labeling updates, and compliance initiatives to maintain product registration and regulatory compliance.


• Serves as a subject matter expert on regulatory requirements, guidelines, best practices including training, mentorship, and guidance to regulatory team members and crossfunctional stakeholders.


• Develops and maintains familiarity with Vitalant operations to support effective coordination of service delivery and customer support. Requires periodic visits to blood center operating units to determine effectiveness of business systems support and opportunities for improvement.


• Prepares and presents regulatory updates, progress reports, strategic recommendations to the senior and/or executive leadership team, and regulatory governance committees pertaining to global development plans to achieve objectives while driving regulatory excellence within the organization.

Requirements

Knowledge/ Education Licenses

Bachelor's degree in scientific discipline such as life sciences, pharmacy, biosciences required.

Advanced degree preferred.

Certifications

RAPS Regulatory Affairs Certification (RAC) Certification preferred.

Experience

Eight years of experience in regulatory affairs within the pharmaceutical or biotech industry required.

Five years leadership experience required.

Strong knowledge of regulatory requirements and guidelines including the FDA and ICH guidelines with experience in interacting with regulatory authorities required.

Skills/ Abilities

Must possess the skills and abilities to successfully perform all assigned duties and responsibilities.

Must be able to maintain confidentiality.

Strong interpersonal and communication skills to engage and collaborate with internal and external stakeholders.

Must have analytical, statistical, personal organization, and problem-solving skills.

Able to organize, prioritize, and execute a variable workload and multiple priorities.

Growth mindset and ability to drive growth and change within the organization.

Able to manage customer interactions and resolve operational and service level issues productively and efficiently.

Effective oral and written business communication skills.

Ability to identify regulatory risks and opportunities.

Ability to work in a team environment and participate as an active member of management.

Must have proficient computer skills.

Ability to travel (< 20%).

Summary

About Us

Vitalant is one of the nation's largest nonprofit blood and biotherapies healthcare organizations, providing hospitals and patients across the U.S. a safe blood supply, specialized laboratory services, transfusion medicine expertise and world-renowned research. We have a network of 115 donation centers across the U.S. and host approximately 60,000 bl ood drives annually. Vitalant provides blood and special services to patients in more than 900 hospitals across the U.S. where millions of people depend on blood donations from our generous donors.

Vitalant is committed to fostering a diverse and inclusive workplace built on a foundation of respect, integrity, teamwork, and excellence. Through our DEI strategic plan, we create opportunities for employees of all backgrounds to feel valued, seen and heard. We believe this mission drives creativity and innovation, as employees experience an environment conducive to personal growth and career development.

EEO/Minorities/Females/Disabled/Veterans

Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e-mail to Careers@vitalant.org to let us know the nature of your request.

For more EEO information about applicant rights click here