Regulatory affairs concern government-regulated businesses. These are typically involved in the development, testing, manufacture, and marketing of pharmaceuticals, agrochemicals, cosmetics, etc. In the capacity of VP of regulatory affairs, we oversee all aspects of our organization’s regulatory affairs. We are experts of the relevant regulatory landscape. We provide strategic insight on what products are most likely to move through the regulatory process, influencing decisions related to product development. We develop regulatory plans and oversee their successful implementation. Our goal is to achieve compliance, on-time submission and first-time acceptance of products. To attain this, we work together with all departments throughout the organization. We also lead the activities and staff of our organization's regulatory affairs department, and assist as a liaison between the organization and regulatory authorities.
Core tasks:
- reviewing and approving documentation to ensure compliance with regulatory requirements
- acting as main point of contact for regulators
- leading on-site audits
- collaborating in product development projects and maintaining certifications
- developing regulatory strategies for life cycle management and expansion of manufacturing