Position Qualifications and Experience Requirements
A bachelor’s degree in biological or chemical sciences, or a related field is required; an advanced degree (e.g., MS, PhD) is preferred.
Over 5 years of progressive experience in regulatory roles within the biologics or plasma industry, demonstrating increasing levels of responsibility.
Strong technical foundation with in-depth knowledge of global regulations and international standards governing drug product development, manufacture, registrations, and life-cycle management.
Proven expertise in authoring, reviewing, and managing regulatory submissions at both federal and state levels, ensuring accuracy, compliance, and timely delivery.
Demonstrated ability to lead cross-functional teams and collaborate effectively with key stakeholders.
Skilled in motivating, mentoring, and guiding diverse teams within a matrixed organizational structure, fostering a culture of accountability and excellence.
Exceptional oral and written communication skills, with a strong ability to negotiate, influence, and represent regulatory positions effectively.
Committed to the highest standards of compliance, integrity, and adaptability, with a strong focus on aligning regulatory strategy with evolving business needs.
Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve goals.
Ensures Accountability: Follows through on commitments and makes sure others do the same; Acts with a clear sense of ownership; Takes personal responsibility for decisions, actions, and failures; Establishes clear responsibilities and processes for monitoring work and measuring results; Designs feedback loops into work.
Drives Results: Has a strong bottom-line orientation; Persists in accomplishing objectives despite obstacles and setbacks; Has a track record of exceeding goals successfully; Pushes self and helps others achieve results.
Drives Vision & Purpose: Talks about future possibilities in a positive way; Creates milestones and symbols to rally support behind the vision; Articulates the vision in a way everyone can relate to; Creates organization-wide energy and optimism for the future; Shows personal commitment to the vision.
Instills Trust: Follows through on commitments; Is seen as direct and truthful; Keeps confidences; Practices what he/she preaches; Shows consistent between words and actions.
Communicates Effectively: Is effective in a variety of communication settings: one-on-one, small and large groups, among diverse styles and position levels, with internal and external stakeholders/audiences. Attentively listens to others; Adjusts to fit the audience and the message; Provides timely and helpful information to others across the organization; Encourages the open expression of diverse ideas and opinions.
Builds Effective Teams: Establishes common objectives and a shared mindset; Creates a feelings of belonging and strong team morale; Shares wins and rewards team efforts; Fosters open dialogue and collaboration among the team.
Drives Engagement: Structures the work so it aligns with people’s goals and motivators; Empowers others; Makes each person feel his/her contributions are important; Invites input and shares ownership and visibility; Shows a clear connection between people’s motivators and the organizational goals.
Manages Ambiguity: Deals comfortably with the uncertainty of change; Effectively handles risk; Can decide and act without the total picture; Is calm and productive, even when things are up in the air; Deals constructively with problems that do not have clear solutions or outcomes.
Collaborates: Works cooperatively with others across the site, matrix, network and enterprise to achieve shared objectives; Represents own interests while being fair to others and their areas; Partners with others to get work done; Credits others for their contributions and accomplishments; Gains trust and support of others.
Decision Quality: Makes sound decisions, even in the absence of complete information; Relies on a mixture of analysis, wisdom, experience, and judgment when making decisions; Considers all relevant factors and uses appropriate decision-making criteria and principles; Recognizes when a quick 80% solution will suffice.
Global Perspective: Looks toward the broadest possible view of an issue or challenge; Thinks and talks in global and network terms; Understands the position of the organization within a global, network and enterprise context; Knows the impact of global trends on the organization.
Being Resilient: Is confident under pressure; Handles and manages crises effectively; Maintains a positive attitude despite adversity; Bounces back from setbacks; Grows from hardships and negative experiences.