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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. Supports business development activities, serving as regulatory expert as part of cross-functional diligence teams to assess external assets/opportunities. Acts as a resource to the broader regulatory function, including mentor-ship of less experienced staff.

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 regulatory strategies for US and international markets.
  • Represents the regulatory function on cross-functional development teams
  • Plans, prepares, and reviews submissions to regulatory authorities 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). Works with regulatory submissions coordinator to develop submission timelines and work with cross-functional teams to planned objectives
  • Serves as the primary point of contact with Regulatory Authorities and develops strong working relationships with counterparts of FDA, EMA, and other regulatory authorities
  • Interacts with regulatory agencies, coordinating the preparation and supporting documentation as well as leading meetings and other interactions; maintains correspondence and other records of interaction.
  • Manages all maintenance plans for regulatory investigative and marketing applications for assigned projects.
  • 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 external departments
  • 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 a plus.

Must possess:

  • Thorough knowledge of US and international regulations as they apply to pharmaceutical and biologic drug development
  • Previous experience managing development of INDs and other global clinical trial applications
  • Experience managing development of NDAs,/MAAs, as well as considerable experience leading regulatory agency interactions, meetings (including Advisory Committees or Scientific Advise procedures)
  • Full lifecycle experience from early development to managing marketed products
  • Ability to work in a cross-functional team environment and a flexible team-oriented perspective
  • Excellent verbal and written communication skills as well as interpersonal, management, and organizational skills
  • Demonstrated problem solving abilities and conflict resolution skills
  • Proficiency in MS Office applications and internet researching
  • 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 for designated function(s) 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.  Erroneous decisions will have a serious impact on the overall success of functional area and may impact the long term success of the company.

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.

ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

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