Global RA Head

Proclinical is currently seeking a Head of Regulatory Affairs for a biotechnology firm located remotely in the east coast. Successful candidate will be responsible for developing and implementing long and short-term planning of regulatory strategies that impact the company's goals and developing and delivering regulatory activities to ensure effective achievement of regulatory/business objectives.

Job Responsibilities:

• Lead the regulatory affairs activities with responsibilities for the oversight and implementation of regulatory strategy and activities to meet regulatory requirements for existing and future pipeline assets.
• Formulate and oversee implementation of regulatory strategy and activities needed to secure approvals for first in human clinical trials.
• Plan, coordinate, and lead meetings with FDA, EMA and other international regulatory authorities.
• Serve as the primary contact with key personnel in FDA CDER review divisions, OPDP and ex-US regulatory bodies.
• Provide regulatory leadership for due diligence activities, with investors and partner organizations.
• Manage coordination, preparation and timely submission of regulatory documents.
• Work collaboratively across functions and teams to develop and implement the Company's regulatory strategies and respond to regulatory authorities, as needed.
• Provide advice on regulatory issues to project teams.

Skills and Requirements:

• Experience with regulatory processes, including meeting request procedures, preparation and submission of briefing documents, annual and other updates and other product submission requirements with the FDA, EMA and other international regulatory authorities.
• Track record of pharmaceutical regulatory filings, in the early stages of development.
• Experience working in the therapeutic area of oncology, immunology and/or orphan/rare diseases.
• Strong time management, process and project management, interpersonal and organizational skills.
• Experience with effective local project team regulatory leadership and management oversight.
• Demonstrated management and leadership skills of technical personnel.
• Excellent teamwork and collaboration skills.
• Fluent knowledge of all stages of pharmaceutical drug development and manufacturing, process validation, analytical operations, compliance and documentation.
• Experience with and maintenance of a good working relationship with multiple divisions within the FDA is strongly preferred.
• Able to work across multiple functions and geographies (e.g., US and non-US).
• Excellent communication, strong networking capabilities and presentation skills.
• Solution oriented with the ability to multi-task.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nicholas Walker at (+1) 646-367-2908 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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