Senior Regulatory Affairs Manager

Description:

Responsibilities

Regulatory Strategy Development: Develop and implement regulatory strategies for new product development, including the preparation and submission of regulatory documents, in alignment with company goals and regulatory requirements.

Regulatory Submissions: Prepare, review, and submit regulatory submissions to health authorities (e.g., FDA, EMA) for product approvals, including investigational new drug applications (INDs), new drug applications (NDAs), marketing authorization applications (MAAs), and variations/supplements.

Compliance Management: Ensure compliance with relevant regulations, guidelines, and standards throughout the product lifecycle, including monitoring changes in regulatory requirements and communicating their impact to cross-functional teams.

Regulatory Intelligence: Stay updated on regulatory developments, industry trends, and best practices to proactively identify potential regulatory risks or opportunities and advise the organization accordingly.

Cross-functional Collaboration: Collaborate closely with internal stakeholders, such as Research and Development, Quality Assurance, Manufacturing, Clinical Development, and Commercial teams, to provide regulatory guidance and support throughout the product lifecycle.

Regulatory Documentation: Develop, review, and maintain regulatory documents, such as protocols, investigator brochures, informed consent forms, and labeling, to ensure compliance with regulatory requirements and guidelines.

Regulatory Agency Interactions: Serve as the primary point of contact for regulatory agencies during inspections, audits, and regulatory submissions, ensuring effective communication and timely responses to queries or requests for additional information.

Regulatory Compliance Training: Provide training to internal teams on regulatory requirements, guidelines, and procedures to foster awareness and ensure adherence to regulatory standards.

Risk Assessment and Mitigation: Identify potential regulatory risks, assess their impact on the organization, and develop mitigation strategies to proactively address and minimize those risks.

Regulatory Compliance Audits: Conduct internal audits to ensure compliance with regulatory requirements, identify areas for improvement, and implement corrective and preventive actions as needed.

Qualifications And Skill

A minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry.

Strong knowledge of global regulatory guidelines and requirements, including FDA, EMA, and ICH guidelines.

Experience in preparing and submitting regulatory documents, such as INDs, NDAs, MAAs, and variations/supplements

Familiarity with pharmaceutical development processes and clinical trial regulations.

Excellent written and verbal communication skills with the ability to effectively interact with cross-functional teams and regulatory agencies.