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Biotechnology Associate Director Jobs in Boston, MA

Lonza

Associate Director Business Development

Boston, MA · On-site

$150K - $200K/yr

Fully Remote We are seeking an Associate Director of Business Development to drive growth across targeted accounts in biotech, pharmaceutical, academic, and venture capital-backed organizations in ...

Lonza

Associate Director Business Development

Boston, MA · On-site +1

$150K - $200K/yr

Fully Remote We are seeking an Associate Director of Business Development to drive growth across targeted accounts in biotech, pharmaceutical, academic, and venture capital-backed organizations in ...

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Biotechnology Associate Director information

What does a biotechnology associate director do?

A Biotechnology Associate Director oversees research and development projects within biotech organizations, ensuring that scientific and business objectives are met. They manage teams of scientists and technical staff, coordinate cross-functional projects, and are responsible for regulatory compliance and quality assurance. Additionally, they play a key role in strategic planning, budgeting, and communicating progress to senior leadership. Their work helps guide the company’s innovation pipeline and ensures that products move efficiently from concept to market.

What are the key skills and qualifications needed to thrive as a biotechnology associate director?

To thrive as a Biotechnology Associate Director, you need advanced knowledge in molecular biology or related life sciences, extensive research experience, and a graduate degree (often a Ph.D.) in biotechnology or a similar field. Familiarity with laboratory information management systems (LIMS), regulatory compliance standards (like FDA or EMA), and project management tools is typically required. Strong leadership, strategic thinking, and communication skills distinguish top performers in this role. These competencies are crucial for leading teams, ensuring regulatory compliance, and driving the successful development of innovative biotech solutions.

What are some common challenges biotechnology associate directors face when leading cross-functional teams?

Biotechnology Associate Directors often navigate the complexities of coordinating efforts between research scientists, regulatory affairs, manufacturing, and commercial teams. One common challenge is aligning diverse priorities and timelines while ensuring compliance with strict industry regulations. Effective communication and adaptability are essential to foster collaboration, resolve conflicts, and keep projects on track. Successfully managing these dynamics leads to efficient product development and positive team outcomes.

What is the difference between Biotechnology Associate Director vs Biotechnology Scientist?

AspectBiotechnology Associate DirectorBiotechnology Scientist
Required CredentialsMaster's or PhD in Biotechnology, Life Sciences, or related field; extensive industry experienceMaster's or PhD; focus on research and development
Work EnvironmentLeadership roles in R&D teams, project management, strategic planningLaboratory research, experimental design, data analysis
Employer & Industry UsageBiotech companies, pharmaceutical firms, biotech divisionsResearch institutions, biotech companies, academia
Common Search & ComparisonOften compared for leadership and strategic rolesFocused on scientific research and experimentation

The Biotechnology Associate Director typically holds a leadership position overseeing research teams and strategic projects, requiring extensive experience and advanced degrees. In contrast, a Biotechnology Scientist primarily conducts laboratory research and experiments. Both roles are vital in biotech companies, but they differ in responsibilities, focus, and career level.

What are popular job titles related to Biotechnology Associate Director jobs in Boston, MA?

For Biotechnology Associate Director jobs in Boston, MA, the most frequently searched job titles are:

What job categories do people searching Biotechnology Associate Director jobs in Boston, MA look for?

The top searched job categories for Biotechnology Associate Director jobs in Boston, MA are:

What cities near Boston, MA are hiring for Biotechnology Associate Director jobs?

Cities near Boston, MA with the most Biotechnology Associate Director job openings:

Biotechnology Associate Director jobs near you
Infographic showing various Biotechnology Associate Director job openings in Boston, MA as of August 2026, with employment types broken down into 96% Full Time, and 4% Contract. Highlights an 78% In-person, 6% Hybrid, and 16% Remote job distribution.

Associate Director/Director Regulatory Affairs

Stirling QR

Boston, MA

$175K - $200K/yr

Full-time

Re-posted 17 hours ago

Job description

Associate Director, Regulatory Affairs
Location: Boston, MA (Hybrid or East Coast, USA)
Employment Type: Full-time, Permanent

About the Company
Our client is a growing consultancy supporting innovative biotechnology and pharmaceutical companies across all stages of development. They are known for helping clients achieve regulatory success through deep scientific understanding and pragmatic regulatory strategy.

Role Overview
We are seeking an experienced Associate Director of Regulatory Affairs who brings strong hands-on expertise in U.S. regulatory submissions. This is a strategic and execution-focused role suited for someone who thrives in a client-facing environment, enjoys variety, and wants to remain closely involved in submission delivery.

This position is hands-on with no direct reports, working across multiple client programs and supporting regulatory strategy and execution from early development through product registration.

Key Responsibilities

  • Develop and implement U.S. regulatory strategies for biotechnology and pharmaceutical programs from early to late stage.

  • Prepare, author, and manage regulatory submissions including INDs, NDAs, and BLAs.

  • Support client interactions with the FDA, including preparation for and participation in pre-IND, Type B, and Type C meetings.

  • Contribute to the preparation of documentation such as PSPs, Orphan Drug Designations, and expedited program applications.

  • Provide regulatory guidance across multidisciplinary teams including CMC, clinical, and nonclinical functions.

  • Monitor U.S. and global regulatory trends, advising clients on implications for their programs.

  • Serve as a trusted regulatory partner to clients, balancing tactical execution with strategic thinking.

Qualifications

  • Minimum of 10–12 years’ experience in Regulatory Affairs supporting biologics or pharmaceutical development.

  • Proven experience preparing and managing major regulatory submissions (INDs, NDAs, BLAs).

  • Strong knowledge of FDA processes, meetings, PSPs, and Orphan Drug regulations.

  • Excellent communication and interpersonal skills, confident in working directly with clients and cross-functional teams.

  • Demonstrated ability to operate autonomously in a consultancy or fast-paced environment.

Desirable Experience

  • Exposure to EU regulatory or other international submissions.

  • Experience with medical device or combination product submissions.

  • Understanding of CMC and/or nonclinical regulatory requirements.

Why Join

  • Opportunity to work with diverse, cutting-edge biotech and pharma innovators.

  • Blend of hands-on project delivery and strategic client engagement.

  • Collaborative, science-driven consulting culture with genuine autonomy.