The Associate Director, Regulatory Affairs (Regulatory Intelligence), will be responsible for monitoring, analyzing, and interpreting global regulatory developments to ensure the company's compliance and strategic positioning in the pharmaceutical market. This role involves collecting and disseminating regulatory information, providing insights to internal stakeholders, and supporting the development of regulatory strategies. Supports the Senior Director, Regulatory Affairs (Labeling/Ad-Promo), in efforts to influence the regulatory environment.
Key Accountabilities:- Proactively monitors and assesses global regulatory environments for emerging changes in laws, regulations, and guidance impacting drug and device development.
- Tracks and evaluates updates from key regulatory authorities (e.g., FDA, EMA), industry associations, and external intelligence sources.
- Maintains and continuously enhances regulatory intelligence databases and tools to ensure accurate, timely, and efficient dissemination of information.
- Analyzes regulatory developments, including guidance documents, policies, and regulations, to determine potential impact on internal processes, development programs, and regulatory strategies. Anticipates and tracks regulatory changes over time, delivering timely, accurate, and actionable updates to impacted stakeholders across the organization.
- Partners with Quality to ensure appropriate change control processes are initiated and tracked through implementation when regulatory changes impact internal procedures.
- Translates complex regulatory information into clear, actionable insights for cross-functional stakeholders.
- Develops and delivers regulatory intelligence communications, including newsletters, alerts, trackers, and periodic reports.
- Responds to internal inquiries by providing tailored regulatory intelligence summaries and detailed analyses to support decision-making.
- Leads and facilitates regulatory intelligence meetings to include review and discussion of ad hoc query requests, regulatory background package requests, health authority guidance, Federal Register notices, public commenting opportunities, newsletter content, training sessions, and knowledge-sharing forums.
- Coordinates cross-functional discussions to evaluate the impact of new or revised regulatory requirements. Collaborates closely with key functions, including Quality, Pharmacovigilance, Clinical, CMC, and Regulatory Affairs, to ensure alignment and effective implementation.
- Leads the regulatory public commenting process and identifies opportunities to engage with external stakeholders on draft regulations, guidance, and policies.
- Supports the development, coordination, and submission of company comments to regulatory authorities and industry organizations.
- Confirms the list of upcoming regulatory meetings/workshops/conferences remains current.
- Drives continuous improvement of regulatory intelligence processes, systems, and tools to enhance efficiency and value. Authors and conducts periodic review of regulatory intelligence Standard Operating Procedures or work practices.
- Manages and maintains internal knowledge management platforms (e.g., SharePoint, intranet) to ensure accessible and up-to-date information. Develops, reviews and updates the Regulatory Intelligence homepage on the Global Regulatory Affairs Portal.
- Contributes to cross-functional initiatives and organizational projects by providing regulatory intelligence expertise and strategic insight.
- Manages onboarding and offboarding of regulatory intelligence team members and provides input on team member performance. Provides leadership, coaching, and day-to-day oversight for direct reports within Global Regulatory Intelligence, fostering their professional growth and development.
Position RequirementsEducation and Experience:- Bachelor's degree in life sciences, law, public policy, or a related field.
- A Master's degree or higher is preferred.
- Minimum 8 years' experience in pharmaceutical regulatory affairs, including 6 years' experience in regulatory intelligence.
- Demonstrates solid working knowledge of the drug, biologic, and device development process, laws, regulations, and guidelines from FDA, EMA, PMDA, ICH, etc.
- Demonstrates understanding of the major regional and global industry association priorities (e.g., PhRMA, EFPIA, JPMA, etc.).
- Previous interactions with FDA or other health authority are desirable.
- Proficient in using regulatory intelligence tools and databases.
Key Competencies:- Analytical thinking, problem solving and decision making: Demonstrates strong analytical and critical thinking skills, with the ability to evaluate complex issues, identify risks and opportunities, develop practical and achievable solutions, and make sound, data-driven decisions
- Strategic thinking & regulatory innovation: Capable of strategic thinking and proposing innovative solutions involving regulatory issues, while being a team player who invites response and discussion
- Performance & accountability: Comfortable in a fast-paced, results-driven, and highly accountable work environment
- Independence & team effectiveness: Demonstrated ability to work independently with minimal supervision while also contributing effectively as a collaborative team member. Balances individual accountability with a commitment to supporting team goals, sharing knowledge, and fostering a positive and productive work environment.
- Attention to detail: Strong attention to detail, ensuring accuracy, quality, and consistency in all work products
- Multitasking:Demonstrates the ability to effectively prioritize, organize, and manage multiple tasks, projects, and competing priorities simultaneously while meeting deadlines and maintaining high standards of performance
Key Capabilities:- Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
- Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
- Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
- Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
- Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
- Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
- Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
- Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
- Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
- Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
