Remote: Senior Director Regulatory Affairs

Shepherd Regulatory Search has been engaged for a newly created Remote Senior 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. 

Location: Remote

Responsibilities:

• Oversees the writing, editing, reviewing, and compiling of documents needed for regulatory submission activities for US and global assigned products.
• 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 other 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.
• Research and identify new opportunities outside of assigned work that augments the Company’s mission, vision, values, and goals.
• Effectively manages and mentors regulatory staff.
• Oversees assigned external vendors and contractors responsible for providing regulatory support functions to ensure goals are achieved.
• Primary liaison with regulatory agencies and interacts with senior management to report on project or program milestones.
• Provides strategic or operational input to 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.
• Fully involved and responsible for all areas of communication with FDA and other government regulatory authorities.

Experience:

• Experience in Cardiology is strongly desired.
• BS/BA degree in a scientific/health sciences discipline.
• 10+ years experience in pharmaceutical Regulatory Affairs.
• Experience preparing 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.
• Management 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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