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US Regulatory Lead

Reference Number: 3103
Location: NJ

Our client is a rapidly growing, specialty pharmaceutical company.  They have asked us to assist them in their search for a US Regulatory Lead.

Major tasks and responsibilities will include:

  • Manages the maintenance of FDA approvals (NDAs, BLAs etc.) in compliance with relevant regulatory legislation and guidelines.
  • Defines regulatory strategies for marketed products in line with commercial and company strategies, consulting with appropriate departments where necessary.
  • Representation of regulatory affairs at project team and LMR team meetings.
  • Ensures the preparation, reviews and approves submission and management of regulatory submissions (paper and electronic) in compliance with the relevant legislation or guidelines and within timelines agreed with management or defined by legislation; ensuring the monitoring and facilitation of progress.
  • Reviews advertising, promotions and other related materials for assigned products to ensure compliance with applicable FDA laws, regulations and guidance.
  • Manages and approves the core regulatory documents such as Prescribing Information.
  • Stays abreast of all relevant regulatory and industry changes and updates related to FDA guidance, warning letters, enforcement actions and regulations and communicates to appropriate internal and external personnel in a timely manner, highlighting the implications of the changes.
  • Manages the preparation, attendance and follow-up of meetings with Regulatory Agencies including the generation of briefing documents and minutes.
  • Provides support for regulatory activities associated with due diligence for in- and out-licensing activities.
  • Management of the provision of information requested by regulatory authorities.
  • Ensures that new safety information received is acted upon, as appropriate, in a timely manner.
  • Manages inspections/audits of the US office by regulatory agencies.
  • Ensures the maintenance of paper and electronic records of all submissions and communications with regulatory authorities, and any supporting documentation.
  • Identifies, retains and manages external experts associated with regulatory activities, as needed.
  • Ensures all essential regulatory processes are written, incorporated into and controlled by the company’s Quality Assurance system.
  • Obtains costs for regulatory activities and inputs into budgetary discussions.
  • Ensures that contracts with third-party Service Providers for regulatory activities include appropriate delegation of responsibilities and deliverables, and are monitored for compliance with the company’s core policies and SOPs.
  • Line management of staff where direct reports assigned.
  • Performs regulatory assessment of any proposed change under company Change Control system for impact on registered details for products.
  • Decides the final content of regulatory submissions ensuring an internal QC check prior to submission, liaising with the Head of Regulatory Affairs where necessary.
  • Decides regulatory strategy for pre- and post-marketing activities in conjunction with the Head of Regulatory Affairs, and where necessary other disciplines.
  • Selects staff in conjunction with the Head of Regulatory Affairs and the Human Resources Department.
  • Decides and approves regulatory content of product packaging artwork.
  • Task delegation and deliverables in contracts with external vendors involved in regulatory activities.
  • Sits on the US Leadership Team contributing to the overall success of the US business.
  • Involvement in the selection of junior regulatory staff, development and training.

We seek candidates with the following qualifications:

  • Minimum of 5 years of experience in regulatory affairs in the pharmaceutical industry.
  • Expert regulatory knowledge.
  • Good leadership and management skills.
  • Excellent negotiation, verbal and written communication and interpersonal skills.
  • Strategic thinker with the ability to develop global regulatory strategy whilst balancing local/affiliate needs.
  • Good analytical and problem solving skills.
  • Good organizational and project management skills and attention to detail.
  • Ability to understand and present complex scientific arguments.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3103. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.