Regulatory Affairs Business Unit Leader

BIOLOGICS CONSULTING GROUP INC•Alexandria, VA

About The Position

The role includes leadership of 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 leader is expected to 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, goal attainment, and 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 of the regulatory affairs team members in line with the growth objectives of the Company as defined by Management (65% of time). Billable/consulting duties (35% of time) will include providing direct consultation with clients 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 itself primarily supports large cross-functional projects that utilize specialists from other business units, including the CMC, clinical, nonclinical, regulatory operations, and medical devices business units, as well as external partners. Biologics Consulting Group, Inc. works with medical device, biologics, and pharmaceutical companies to advance patient health.

Requirements

Bachelor’s degree in a scientific, regulatory, or engineering discipline; an advanced degree is highly preferred.
Minimum of ten (10) years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, with at least five (5) years in a leadership role in regulatory 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
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 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.
Project Management Professional (PMP) or Lean Six Sigma certification or equivalent experience is highly desirable.
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 (i.e., One Pager, Office Timeline Pro, etc.)
Comprehensive knowledge of global drug and biologics regulations and standards (FDA, EMA, Asia-Pacific etc.) with a commitment to staying up to date on global regulatory requirements and understanding of global regulatory pathways, expedited programs, and dossier structures.
Strong leadership and team management capabilities with a focus on mentorship and professional development
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

Nice To Haves

Project Management Professional (PMP) or Lean Six Sigma certification or equivalent experience is highly desirable.

Responsibilities

Lead and mentor a team of strategic regulatory consultants 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, and provide updates to executive management as needed
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
Identify and propose innovative regulatory pathways and planning scenarios that align with global regulatory expectations and business objectives.
Develop strategy and implement 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, Human Resources, the Executive team, and other group leaders in identifying best practices for onboarding, recruiting, staff growth, and business development to meet business goals.
Establish clear performance goals and deliver regular feedback to team members.
Display leadership ability, including the ability to create a positive and collegial culture and motivate the regulatory affairs team to perform effectively.
Serve as a positive, energetic, forward-looking leader for the team.