Job Description

Job Overview

We are seeking an experienced Director of Regulatory Affairs in the biotech or pharmaceutical industry. The Director will manage the entire regulatory process from proof of concept to postapproval activities. This leadership role will drive regulatory strategy ensuring compliance with FDA regulations ICH guidelines and other relevant global regulatory requirements. The ideal candidate will have expertise in regulatory submissions including NDA/MAA/CTD filings and be highly experienced in navigating complex regulatory landscapes.

Key Responsibilities

• Lead Regulatory Strategy: Drive the development and implementation of regulatory strategy for projects across multiple phases of product development ensuring alignment with global registration strategy.
• Manage Regional & Global Teams: Act as the Regional Regulatory Leader (RRL) for U.S. and/or European regulatory activities collaborating with the Global Regulatory Team (GRT) to ensure seamless integration of regulatory activities.
• Regulatory Submissions: Plan prepare and manage regulatory submissions including NDA MAA and CTD submissions ensuring timely and compliant filings with Health Authorities.
• Collaborate Across Functions: Work closely with crossfunctional teams (including clinical nonclinical and CMC departments) to review and contribute to regulatory documents such as study reports protocols investigator brochures and CMC data.
• Regulatory Compliance: Ensure all activities comply with applicable regulations and guidelines including FDA EMA and other global health authorities and manage interactions with regulatory agencies.
• Mentor & Develop Talent: Provide guidance training and mentoring to junior staff and support their professional development within the regulatory affairs function.
• Health Authority Liaison: Lead and coordinate meetings with regulatory agencies document regulatory authority interactions and manage submission strategies in accordance with local requirements.
• Regulatory Strategy Development: Contribute to the global regulatory functional plan leveraging expertise in recent regulatory guidance documents and Advisory Committee proceedings to shape strategies for successful product approvals.
• Strategic DecisionMaking: Assess regulatory challenges and propose solutions to mitigate risks contributing to the development of regulatory strategy documents and advising teams on major regulatory issues.

Core Competencies

• Leadership & Communication: Strong interpersonal and communication skills with the ability to present complex regulatory concepts clearly to senior management and project teams.
• Regulatory Expertise: Indepth knowledge of FDA regulations ICH guidelines and the regulatory requirements for biotech and pharmaceutical product development including clinical trials CMC and postmarketing strategies.
• Regulatory Submissions & Approvals: Proven track record of success in regulatory submissions (e.g. NDA MAA CTD) with experience in regulatory authority negotiations and meeting leadership.
• Project Management: Ability to lead and manage multiple projects simultaneously in a fastpaced matrixed environment ensuring the successful delivery of regulatory milestones.
• ProblemSolving & DecisionMaking: Strong analytical skills to identify key regulatory issues and provide actionable solutions to support product development.
• Commercial Awareness: Experience in brand optimization and postmarketing strategies with an understanding of the commercial implications of regulatory decisions.
• Global Regulatory Experience: Expertise in interacting with the FDA and other global health authorities as well as navigating regulatory requirements for various markets.
• Team Collaboration: Proven ability to collaborate with crossfunctional teams providing guidance on regulatory requirements and ensuring alignment with development strategies.

Requirements

• Education: Master s degree in a relevant scientific discipline (e.g. Pharmaceutical Sciences Biology Chemistry).
• Experience: 812 years of experience in regulatory affairs within the biotech or pharmaceutical industry with at least 8 years focused on regulatory strategy and submissions.
• Specialized Knowledge: Experience with clinical research NDA/MAA submissions and global regulatory frameworks. Familiarity with FDA regulations and ICH guidelines is essential.

This role offers the opportunity to shape regulatory strategy and influence the development of innovative products within a leading biotech or pharmaceutical organization. If you are an experienced regulatory professional with a passion for driving successful product approvals and ensuring regulatory compliance we encourage you to apply at .

Experience: 8-12 years of experience in regulatory affairs within the biotech or pharmaceutical industry, with at least 8 years focused on regulatory strategy and submissions. Specialized Knowledge: Experience with clinical research, NDA/MAA submissions, and global regulatory frameworks. Familiarity with FDA regulations and ICH guidelines is essential.

Education

Master s degree in a relevant scientific discipline (e.g., Pharmaceutical Sciences, Biology, Chemistry).

Job Tags

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