Remote Position

Shepherd Regulatory Search has been engaged for a newly created Associate Director Global Regulatory Affairs position. In this role, you will be the point of contact for all agency interactions.

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 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 of the Company,
• 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 the 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
• Easily gains trust and support of peers; encourages collaboration

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