Responsibilities:

• Develop and execute regulatory strategies that align with the company’s business objectives and ensure adherence to relevant regulations and guidelines.
• Manage the preparation and submission of regulatory documents, including regulatory filings, registrations, and certifications.
• Foster positive relationships with regulatory authorities and external stakeholders.
• Lead and oversee a team of regulatory professionals to provide effective and efficient regulatory support for the company’s products and activities.
• Coordinate and manage regulatory inspections and audits, and ensure appropriate corrective and preventive actions are taken in response to any findings.
• Stay updated on changes to regulatory requirements and guidelines, and communicate these changes to relevant stakeholders promptly.
• Offer regulatory guidance and support to cross-functional teams, including product development, clinical research, manufacturing, and quality assurance.
• Collaborate with internal and external stakeholders to develop and implement regulatory policies and procedures that align with the company’s overall goals and objectives.
• Ensure timely and accurate reporting of regulatory activities and metrics.

Requirements:

• At least 5 years of experience in regulatory affairs, with at least 2 years in a leadership role.
• Familiarity with a fast-paced, deadline-driven environment.
• Comprehensive knowledge of global regulatory requirements and guidelines for pharmaceuticals, medical devices, or other regulated products.
• Strong leadership and pe
• ople management skills, with the ability to motivate and develop a team of regulatory professionals.
• A bachelor’s degree in a scientific discipline, preferably in life sciences, chemistry, or pharmacy.
• Excellent communication, interpersonal, and problem-solving abilities.
• Ability to work independently and handle multiple projects simultaneously.
• Strong attention to detail and accuracy.