Remote Associate Director Regulatory Affairs

Shepherd Regulatory Search has been engaged for a newly created Remote Associate Director Regulatory Affairs position.  This role will provide regulatory expertise from preclinical through clinical development for assigned programs.

Organization: Our client is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative treatments for severe, rare muscle disorders for which there is a significant unmet medical need. 

Primary Responsibilities:

• Oversees the writing, editing, reviewing, and compiling of documents needed for regulatory submission activities for US and global assigned products.
• Responsible for all areas of communication with FDA and global agencies.
• Provides critical review of all documentation supporting regulatory submissions and communications.
• Prepares and submits regulatory applications, annual reports/IND amendments, and meeting requests to FDA and European regulatory agencies.
• Reviews and prepares responses to requests from regulatory authorities.
• Provides leadership for regulatory document management systems and maintains corporate regulatory files.
• Ensures regulatory milestones are met to support regulatory submission and overall business goals.
• Contribute to the development of regulatory strategies.
• Leads regulatory operations efforts for development programs by working closely with internal functional teams, external vendors, and consultants.
• Oversees external vendors and contractors with responsibility for providing regulatory support to ensure goals are achieved.
• Primary liaison with regulatory agencies § Interacts with senior management to report on project or program milestones.
• Provides strategic or operational input on project team.
• Builds professional and effective external relationships crucial to the success of the organization.
• Works across internal departments to maintain credibility, trust, and support of employees and other stakeholders.

Requirements:

• BS/BA degree in a scientific/health sciences discipline.
• 7+ year’s experience in pharmaceutical Regulatory Affairs.
• Experience in the preparation of submissions, regulatory documents, annual reports, amendments, and supplements.
• Proven ability to strategize with team members on the optimal way of documenting various submissions and determining the preferred plan.
• In-depth knowledge of overall global drug development, expertise on the timeline and process for submissions.
• Expert knowledge of regulations and guidance’s affecting routine regulatory activities and specific therapeutic areas and keeps abreast of the regulatory environment.
• In-depth knowledge of overall global drug development.
• Excellent written, interpersonal, and communication skills.
• Action-oriented and committed to meeting FDA and other regulations while moving projects forward.
• Able to handle changing priorities and multidisciplinary tasks.

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