Head Of Regulatory Affairs

Description:

The preferred candidate should possess a strong foundation in the Pharma and Life Science Industry, engaging proactively in conducting regulatory assessments for Pharma and Medical Devices in close collaboration with both internal and external experts. Proficiency in Clinical Trials, the submissions process, and a comprehensive grasp of the regulatory landscape within the Life Science Industry are essential, given the global clientele served by the company.

In this position, you'll gain valuable mentorship, operate in a dynamic setting overseeing numerous projects, and engage in collaboration with stakeholders across the organization.

📌Responsibilities:

✅Client Satisfaction:

• Manage the Regulatory Affairs team (Pharma, Medical Devices, Clinical Trials) to ensure on-time and quality project delivery.
• Ensure customer satisfaction by advising clients on regulatory matters.
• Lead projects and liaise with experts to understand client scope for proper assistance.
• Meet with clients and present regulatory assessment outcomes during teleconferences or face-to-face meetings.

✅Content Strategy:

• Identify client scope/needs and propose a methodology to address requests.
• Collaborate with Marketing, Product, and Sales teams, providing customer feedback and requests.
• Supervise content on the platform.
• Identify internal areas for improvement and propose best practices to the team.

✅Content Delivery:

• Liaise with clients and SMEs, coordinating with the team for content delivery.
• Write portions of projects and participate in strategy and deliverable development.
• Review technical reports, presentations, and other client deliverables.
• Manage day-to-day RA activities.
• Understand technical project issues and find solutions to problems.

✅Leadership:

• Coach, grow, and develop the team to maximize engagement, performance, and potential.
• Uphold company Culture & Values, fostering a positive team culture where members feel valued, empowered, and developed.
• Communicate transparently with your team, peers, and leaders to maximize information flow and support effective collaboration.

📌Requirements:

• Relevant degree in Pharma, Life Sciences, Biotech industry, or equivalent.
• Minimum 15 years of experience related to responsibilities, including clinical trials regulatory compliance, authoring regulatory dossier documentation, regulatory strategy, product classification, pre-submissions/submissions, etc.
• Ability to embrace and engage in digital and AI strategy.
• Previous experience leading global teams and driving projects to meet deadlines and budgets.
• Detail-oriented with the ability to handle regulatory information and submissions with a high degree of accuracy.
• Excellent communication and client-facing skills.
• Ability to create effective and concise PowerPoints.
• Skilled in human interactions within multicultural teams, including the ability to challenge other experts when justified.
• Enjoys working for innovative companies in challenging and demanding environments.
• Organized, analytical, and result-oriented individual who thrives in a fast-paced entrepreneurial environment.
• Ability to plan and manage multiple priorities concurrently.