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Job Description
Regulatory Affairs Business Unit Leader
BIOLOGICS CONSULTING GROUP INC - 4.0
Alexandria, VA Job Details Full-time 15 hours ago Qualifications Meeting minutes FDA submissions Biotechnology Product development project management Workplace dispute resolution Investigational new drug (IND) applications Team development Documentation tools Product development projects Math Professional development support Pharmaceutical company experience Mentoring Smartsheet Leading team collaboration initiatives Meeting facilitation Presentation preparation Regulatory submission editing and review Communication with regulatory authorities for clinical trials Managing projects Typing Productivity software Cross-functional team management Cross-functional communication Senior leadership
Full Job Description Regulatory Affairs Business Unit Leader Position Summary :
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.
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.
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
Key Performance Indicators:
Achievement of team revenue Quality and timeliness of client deliverables Strengths of client relationships and client satisfaction Mentorship and development of staff Contributions to thought leadership and professional visibility Demonstrated teamwork and leadership capabilities Implementation of scalable project management system across team
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.
