Director of Regulatory Affairs

Kaye/Bassman International; Massachusetts; Remote; USD 220,000 - 240,000; Full time

Job summary

A leading biopharma company is seeking a Director of Regulatory Affairs to spearhead regulatory strategies for their diverse product portfolio. The ideal candidate will have over 10 years of experience in the biotechnology sector, with a proven track record in regulatory submissions and health authority interactions. This remote position offers a competitive salary and the opportunity to shape the future of innovative therapies in oncology and autoimmune diseases.

Benefits

Disability insurance

Vision insurance

Medical insurance

401(k)

Paid maternity leave

Paid paternity leave

Tuition assistance

Qualifications

• 10+ years of relevant Regulatory Affairs experience in biotechnology or pharmaceuticals.
• Experience in leading drug development processes and health authority regulations.
• Proficient in managing IND and clinical trial applications.

Responsibilities

• Lead development and execution of regulatory strategies for clinical-stage biopharma.
• Provide strategic and operational regulatory guidance to development teams.
• Analyze international guidelines and ensure compliance with regulatory requirements.

Skills

Regulatory Affairs

Strategic Thinking

Communication

Project Management

Scientific Evaluation

Education

BA/BS degree in biological/physical sciences

Advanced degrees preferred

Tools

Veeva Vault

MS Office

Job description

Direct message the job poster from Kaye/Bassman International

Experienced Biotech & Pharma & Medical Device Regulatory Affairs & Quality Recruiter | Kaye/Bassman International

Location: Remote

My client is a clinical-stage biopharma company developing a diverse portfolio of assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in oncology and autoimmune diseases. Their portfolio encompasses a wide range of modalities, each with the potential to be first in class.

Position: The Director of Regulatory Affairs will lead the development and execution of comprehensive regulatory strategies across my client’s development programs. This role will ensure alignment with corporate objectives while closely collaborating with cross-functional stakeholders and shaping regulatory strategy across a diverse and evolving product portfolio.

Responsibilities:

• Global regulatory lead, responsible for providing strategic and operational regulatory guidance to development teams, global submission plans, US/EU or other national clinical trial requirements, and health authority interaction leadership.
• Primary point of contact for regulatory authorities and/or contracted regulatory representatives (e.g., CRO local representative).
• Proactively communicate potential regulatory issues and mitigation strategies by facilitating and/or contributing to risk assessments and managing critical issues.
• Analyze international (ICH) and country-specific guidelines, national regulations, and clinical trial/marketing application procedures, and translate complex scientific/technical information into concise written documents and presentations.
• Lead high-quality, on-time regulatory submission execution (IND/CTA/NDA/MAA, as applicable) in compliance with applicable regulatory requirements in a fast-paced matrixed environment and alignment with corporate goals.
• Actively lead or participate in regulatory department infrastructure and capability building, including best practices, templates, training tools, and cross-program knowledge sharing.
• Support due diligence and strategic partnering activities as needed.
• Provide mentorship and coaching to regulatory colleagues to foster a supportive and growth-minded culture.

Requirements:

• BA/BS degree in biological/physical sciences required. Advanced degrees preferred.
• 10+ years of relevant Regulatory Affairs experience in the biotechnology or pharmaceutical industry or a combination of education and experience.
• Direct experience in leading the drug development process, pharmaceutical industry, health authority regulations, healthcare environment, and policies.
• Highly skilled in developing and managing multinational IND and clinical trial applications throughout the product development lifecycle, with a proven track record of significant regulatory accomplishments.
• Experience in autoimmune disease and/or hematology/oncology development
• Demonstrated success in leading teams in the preparation of health authority applications and health authority interactions.
• Independently providing regulatory leadership and guidance on cross-functional teams and working in a matrixed environment.
• Well-versed in evaluating complex scientific information and regulatory guidelines, with a demonstrated ability to formulate recommendations based on assessment.
• Effective communication skills with a demonstrated ability to influence decision-making and/or deliver comprehensive recommendations in written or verbal presentation format.
• Possess strong scientific and business acumen, capable of strategic thinking, planning, and proposing innovative solutions to regulatory challenges.
• Experience with document management and Regulatory Information Management (RIM). Veeva Vault preferred experience.
• Proficient with MS Office tools to perform project management, tracking, writing, and presentation tasks.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Strategy/Planning and Science

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Kaye/Bassman International by 2x

Inferred from the description for this job

Disability insurance

Vision insurance

Medical insurance

401(k)

Paid maternity leave

Paid paternity leave

Tuition assistance

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