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Senior Director, Global Regulatory Affairs

Company: Amikids, Inc.
Location: Marlow
Posted on: May 3, 2021

Job Description:



Senior Director, Global Regulatory Affairs Location Marlow, UK Requisition ID 1821 # of openings 1

SeniorDirector, Global Regulatory Affairs

SUMMARY OF POSITION

The SeniorDirector, Global Regulatory Affairs (Post Approval), is responsible for leading market expansion and post approval activities for the companys portfolio, managing a semi-virtual model of in house expertise and external vendors. As a member of the Global Regulatory Affairs (GRA) senior leadership team, the individual will work closely with the team to develop and align on program and department strategies and partner with internal stakeholders including R&D, Commercial, Marketing, Pharmacovigilance, and Technical Operations to communicate and execute on those strategies in compliance with applicable regulations and standards.

MAJOR ACTIVITIES AND RESPONSIBILITIES
Develops and optimizes the operating model and organizational design of the post approval function to ensure the effective market expansion and maintenance of all products in alignment with the corporate objectives Partners closely with the GRA senior leadership team to develop and align on program and department strategies Ensures close communication with internal stakeholders to ensure all business needs are accounted for in the strategy for market expansion and collaborate with the cross-functional teams Maintains knowledge of global regulatory requirements, actively review new laws/regulatory requirements to maintain proficiency in worldwide regulations and communicates pertinent information to the business Develops and manages team and vendors and monitors spend against approved budgets Works proactively to build contacts with local Health Authorities and build upon and existing network of regulatory contacts Other responsibilities assigned as required
ORGANIZATIONAL STRUCTURE

Reports to VP, Global Regulatory Affairs

QUALIFICATIONS AND BACKGROUND REQUIREMENTS

Educational Requirements and Professional Work Experience
Minimum of a B.S. or B.A. in a scientific discipline or equivalent; an advance degree or Regulatory Affairs Certification is preferred. Minimum of 10+ years of regulatory experience respectively within the pharmaceutical or biotechnology industry Must have an in depth understanding of global regulations and ICH guidance, regulatory documentation, authorization procedures, post-marketing surveillance, quality, marketing, and sales and the drug development process with a hands on approach to leading and managing regulatory activities. Experience communicating directly with regulatory agencies in meetings and correspondence. Experience working with innovator products and designing and executing creative development strategies are highly desirable. Capability to lead and prepare regulatory submissions in line with international or regional requirements and scientific and company policies and procedures. Must be able to innovate, analyze and solve problems with minimal supervisory input. Contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function. Is recognized as an expert resource for Regulatory Advice in other departments
Behaviors
Excellent verbal, written, organizational and interpersonal communication skills Self starter with the ability to work on parallel projects, often with tight timelines; able to set priorities Detail-oriented and highly organized High emotional intelligence and self-awareness Able to work effectively in a cross-functional environment Strong people manager, able to provide honest, timely and respectful feedback to team members Able to resolve conflicts in a positive and collaborative manner Constantly looks for ways to improve (processes, own behaviors) Able to manage up and down
Travel

The role may require up to 25% travel, both domestic and interna

Keywords: Amikids, Inc., Lawton , Senior Director, Global Regulatory Affairs, Other , Marlow, Oklahoma

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