Department: Regulatory Affairs
Reports To: Vice President, Regulatory Affairs
Bachelor’s degree required, advanced degree preferred
The Director, Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders. This individual will manage regulatory aspects of compounds through all phases of development, post-approval, and life-cycle of the product. The incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met. The individual has departmental and corporate level influence and acts as an advisor/liaison to senior management to plan, evaluate and recommend regulatory strategy. Externally, the individual will interface with outside regulatory agencies and business partners regarding development, regulatory, and registration strategies. He/she will also provide line management, people development, and performance management as well as support/lead development and implementation of department policies.
Essential Functions of the job: Responsibilities
- Provides high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions.
- Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
- Oversees the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met.
- Reviews sections of IND/CTA, NDA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
- Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes.
- Maintains awareness of global regulatory environment and assess impact of changes on business and product development programs. Facilitate policy and development of standard interpretation of global regulation.
- Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business
- Trains, develops, and manages an effective regulatory team both via direct and indirect reporting structure.
- Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals
are met through the sharing of knowledge and expertise.
- Manages critical issues, taking leadership for the regulatory contribution
- Responsible for assisting with the development and implementation of regulatory processes
- Recruits, develops, manages and mentors regulatory professionals and helps create a goal oriented culture.
Core Competencies, Knowledge and Skill Requirements:
- Minimum 10 years of experience in the biotechnical or pharmaceutical industry, and a minimum of 5 years’ experience in a Regulatory capacity with a broad background.
- Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas, and prior experience with both small molecules and biologics.
- Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends
- Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments
- Strong business acumen and ability to make sound decisions that contribute positively to the business
- Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.
- Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
Communication & Interpersonal Skills:
- Excellent verbal and written skills; Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders
- Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.
- Strong negotiating skills and ability to think creatively and develop creative solutions
- Proven ability to build trust and respect within the organization.
- Ability to prioritize and handle multiple projects simultaneously.
- Interacts with external business partners and Regulatory Agencies
• 10 – 20% of time, as required
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully. Project Management – Communicates changes and progress; Completes projects on time and budget.