*Please note we are open to Director or Senior Director depending on experience

Position Summary:

Provides regulatory leadership and develops regulatory strategies for products in development to support clinical trial application and marketing approvals in the US and internationally, as well as life cycle management of approved products and maintains compliance with applicable regulatory requirements. Serves as regulatory representative/expert as part of cross-functional development teams and supports business development assessments of external opportunities. Experience in neuroscience drug development, particularly analgesia drug development, highly desirable.

Primary Responsibilities:

• Provides strong regulatory and scientific leadership to the overall development team to ensure that the development plan provides for optimal scientific positioning and highest regulatory probability of success.
• Interprets and applies regulations in the creation of timely and innovative global regulatory strategies.
• Plans, prepares, and reviews submissions to regulatory agencies including FDA, EMA, and other global health authorities to support the conduct of clinical trials and approval of marketing applications (including, but not limited to, Investigational New Drug (IND), Clinical Trial Authorization (CTA), New Drug Application (NDA), and Marketing Authorization Application (MAA), and is responsible for the maintenance of these applications.
• Serves as the primary point of contact with Regulatory Agencies and leads communication/meeting strategy development and execution.
• Works with regulatory operations submissions coordinator to develop submission plans and timelines.
• Demonstrated experience coordinating/managing label development; knowledge of CMC and Advertising and Promotion a plus.
• Acts as regulatory expert for diligence of external assets as part of business development activities.
• Monitors, analyzes, and disseminates intelligence on regulatory matters that may affect ongoing development programs.
• Provides regulatory guidance and/or training to development team functional representatives and RnD/Corporate staff.
• Prepares and revises internal procedures for continuous improvement.
• Manages activities performed by regulatory

Education/Experience/Skills:

Advanced degree in a life science required, e.g. PhD, PharmD or Master's degree. A minimum of 12 years progressively responsible experience in regulatory affairs management in the pharmaceutical/biotechnology with a minimum of 8 years in a leadership role preferred. An equivalent combination of relevant education and applicable job experience may be considered. Experience in neuroscience drug development or pain is a plus.

Must possess:

• Thorough knowledge of US and international regulations as they apply to drug and biologic development.
• Demonstrated experience managing development of INDs and global clinical trial applications and well as NDAs and global marketing applications
• Considerable experience leading regulatory agency interactions, meetings (including e.g. Advisory Committees or Scientific Advice procedures).
• Ability to work in a cross-functional development team environment.
• Excellent scientific/analytical ability.
• Excellent verbal and written communication skills as well as interpersonal, management, organizational and conflict resolution skills.
• Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.
• Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.

Scope:

Establishes strategic plans and goals for the regulatory affairs and R&D functions and may participate with senior management to align objectives across the organization. Develops methods, techniques, and evaluation criteria for projects, programs, and people. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds.

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