Role Overview: As a Regulatory Affairs Executive, you will be responsible for overseeing all regulatory aspects of our company’s products and operations. You will ensure compliance with applicable regulations and standards, manage submissions to regulatory authorities, and provide strategic guidance to support the development and commercialization of products.

Key Responsibilities:

• Regulatory Compliance: Ensure that the company complies with all relevant regulations, guidelines, and standards applicable to its products and operations. Stay updated on regulatory changes and communicate implications to relevant stakeholders.
• Regulatory Strategy Development: Develop and implement regulatory strategies to support the development, registration, and commercialization of products. Work closely with cross-functional teams to align regulatory strategies with business objectives.
• Regulatory Submissions: Prepare, review, and submit regulatory filings, including applications, registrations, notifications, and reports, to regulatory authorities. Coordinate responses to queries from regulatory agencies and ensure timely resolution.
• Product Development Support: Provide regulatory guidance and support to product development teams throughout the product lifecycle, from concept to post-market activities. Review product labeling, packaging, and promotional materials for compliance with regulatory requirements.
• Quality Assurance: Collaborate with quality assurance teams to establish and maintain quality systems that comply with regulatory requirements. Participate in internal and external audits and inspections, ensuring corrective and preventive actions are implemented as necessary.
• Risk Management: Identify regulatory risks and develop risk mitigation strategies to ensure compliance and minimize business impact. Proactively assess regulatory implications of new technologies, processes, and business initiatives.
• Cross-Functional Collaboration: Work closely with cross-functional teams, including R&D, manufacturing, marketing, and legal, to align regulatory activities with business goals and objectives. Communicate regulatory requirements and provide regulatory guidance to support decision-making processes.
• Regulatory Intelligence: Monitor regulatory developments, trends, and best practices relevant to the company’s products and industry. Provide updates and recommendations to senior management and stakeholders to inform strategic planning and decision-making.

Qualifications and Skills:

• Bachelor’s degree in a relevant scientific or technical field; advanced degree (e.g., Master’s or Ph.D.) preferred.
• 5+ years of experience in regulatory affairs within the relevant industry (e.g., pharmaceuticals).
• In-depth knowledge of regulatory requirements and guidelines, including FDA, EMA, ICH, and other global regulatory agencies.
• Strong understanding of product development processes, quality systems, and regulatory submission requirements.
• Excellent communication, negotiation, and interpersonal skills.
• Proven ability to manage multiple projects simultaneously and work effectively in a fast-paced, dynamic environment.
• Strategic thinking, problem-solving, and decision-making skills.
• Regulatory affairs certification (e.g., RAC) is a plus.

Working Conditions:

• This position typically operates in an office environment.
• Occasional travel may be required to attend meetings, conferences, and regulatory agency inspections.