Quality & Regulatory Affairs Lead

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About the role

Lead the development and implementation of quality and regulatory strategies to ensure compliance with all relevant regulations and standards. Oversee the quality management system and regulatory affairs processes to maintain product integrity and safety.

Responsibilities

• Develop and implement quality and regulatory strategies to ensure compliance with all relevant regulations and standards.
• Oversee the quality management system and regulatory affairs processes to maintain product integrity and safety.
• Collaborate with cross-functional teams to ensure alignment on quality and regulatory requirements.
• Manage regulatory submissions and interactions with regulatory authorities.
• Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant industry standards.
• Conduct risk assessments and develop mitigation strategies to address potential quality and regulatory issues.
• Provide guidance and training to internal stakeholders on quality and regulatory matters.
• Stay current with regulatory changes and industry best practices through ongoing education and professional networks.

Requirements

• Bachelor's degree in a related field (e.g., pharmaceutical sciences, chemistry, biology).
• Minimum 7 years of experience in quality assurance, regulatory affairs, or a related field.
• Proven track record of successfully leading quality and regulatory initiatives.
• Experience with GMP, GLP, and other relevant industry standards.
• Strong knowledge of FDA, EU, and international regulatory guidelines.
• Excellent communication and interpersonal skills to collaborate effectively with cross-functional teams.
• Ability to manage multiple projects simultaneously and prioritize tasks effectively.
• Proficiency in Microsoft Office Suite and familiarity with quality management systems (e.g., ISO 13485, ISO 9001).

Qualifications

• PhD in a related field (e.g., pharmaceutical sciences, chemistry, biology) preferred.
• Experience in a leadership role within a regulated environment.
• Knowledge of cGMP, cGLP, and other relevant industry standards.
• Experience with regulatory filings and submissions.
• Experience with risk assessment and management methodologies.
• Experience with quality management systems (e.g., ISO 13485, ISO 9001).

Skills

• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work independently and as part of a team.
• Experience with regulatory databases and software tools.
• Knowledge of regulatory frameworks and compliance requirements.

Benefits

• Competitive compensation package including base salary and performance-based incentives.
• Flexible remote work options.
• Professional development opportunities and training programs.
• Health, dental, and vision insurance coverage.
• Retirement savings plan with company match.
• Employee assistance program.

Pay

Commensurate with experience.

Schedule

Full-time.