Regulatory Affairs Business Unit Leader
(RA Strategy and Project Management)
Position Summary:
The role includes leading the Regulatory Affairs team, responsibility for all team financial KPIs, and providing knowledge, experience, business development support, and direction to achieve company and business unit goals. The incumbent will foster a collaborative, team-oriented environment, ensuring an overall ‘culture of quality’ in the execution of services provided to clients. The Business Unit Leader is responsible for driving performance, achieving goals, and advancing growth strategies. This position requires a balance of client/opportunity oversight, quality management, and people management, along with strategic business development and marketing acumen, with support from regulatory affairs team members, in line with the Company's growth objectives as defined by Management (65% of time).Billable/consulting duties (35% time) will include providing direct client consultation and delivering high-level strategic thinking with operational execution across all stages of product development, registration, and post-marketing.
This individual will lead a team of strategic regulatory experts and experienced operational regulatory project managers at all levels. The team primarily supports large cross-functional projects that engage specialists from other business units, including CMC, clinical, nonclinical, regulatory operations, and medical devices, as well as external partners.
Biologics Consulting Group, Inc. works with medical devices, biologics, and pharmaceutical companies to advance patient health.
Responsibilities:
- Lead and mentor a team of regulatory affairs strategy and project managers with a focus on high-quality and timely delivery of regulatory submissions spanning INDs, BLAs, NDAs, etc.
- Develop and execute an annual strategic business plan for the regulatory affairs consulting practice, ensuring alignment with company goals
- Identify new business opportunities, expand the customer base, and build long-term client relationships
- Monitor industry trends, regulatory changes, and emerging market needs to keep services relevant and competitive
- Serve as the primary point of contact for key clients, providing expert guidance on complex regulatory strategies
- Lead client presentations, negotiations, and communications to maintain high levels of satisfaction and loyalty
- Develop strategy and implement an action plan for capacity planning and growth, including recruitment.
- Work with other team leaders to facilitate the timely identification of resources required to support single and multidisciplinary projects where appropriate
- Collaborate with BD, HR, the Executive team and other group leaders in identifying best practices for onboarding, recruiting, staff growth and business development to meet business goals.
- Demonstrated leadership ability including ability to create a positive and collegial culture and motivate the regulatory affairs team to perform effectively
- Facilitate successful project/program launches while ensuring that the programs run smoothly and in compliance with agreed-upon timelines and budgets.
- Lead the execution of regulatory plans, ensuring alignment between day-to-day operations and broader strategic objectives across global programs.
- Identify and propose innovative regulatory pathways and planning scenarios that align with global regulatory expectations and business objectives.
Requirements:
- Bachelor’s degree in a scientific, regulatory, or engineering discipline; an advanced degree is highly preferred.
- Minimum of 10 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, with at least 5 years in a leadership role in regulatory strategy or regulatory program management
- Proven ability to partner on regulatory strategy and lead execution across all stages of product development, including PIND/IND/BLA/MAA/NDA/ANDA submissions, global registration, and post-marketing activities
- Deep understanding of U.S. regulatory requirements with working knowledge of international (ex-U.S.) regulations and agency expectations, including global regulatory pathways, expedited programs, and dossier structures.
- Exceptional communication and influencing skills, with the ability to synthesize complex regulatory information and translate it into clear recommendations for senior leadership and global stakeholders.
- Demonstrated ability to develop, implement, refine, and leverage project management tools and best practices to enhance visibility, efficiency, cross-functional alignment, and meeting effectiveness across regulatory affairs and project teams.
- Demonstrated experience facilitating cross-functional team meetings, driving structured agendas, documenting decisions and actions, and maintaining strong meeting hygiene and team accountability in a matrixed environment.
- Expert skills required for Smartsheet (Regulatory Activity and Submissions Project Plans) and Microsoft Office Suite
- Expert in creating visuals using PPT generated from timeline integration tools (ie, One Pager, Office Timeline Pro, etc.)
- Must exercise rapid learning ability, attention to detail, excellent computer skills, excellent oral and written communication skills, team player, organized analytical thinker with a high level of energy and self-motivation
- Demonstrated versatility in conflict resolution, problem solving, and working effectively as part of a cross-functional organization.
- Strategic thinking and problem-solving skills, with a strong focus on client satisfaction and business growth
Key Performance Indicators:
- Contribution to team revenue and overall business development
- Implementation of scalable project management system across team
- Quality and timeliness of client deliverables
- Strengths of client relationships and client satisfaction
- Mentorship and development of junior and mid-level staff
- Contributions to thought leadership and professional visibility
- Demonstrated teamwork and leadership capabilities
Essential Skills:
Proficient in Microsoft Office Suite, keyboarding skills, strong documentation skills, math aptitude, diplomacy and leadership skills, professionalism, time management, ability to multitask, able to work independently as well as collaboratively, and able to maintain confidentiality.
The listed requirements are representative of the knowledge, skills, and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
