LFB USA - Vice President Regulatory Affairs

US-MA-Southborough
Job ID
2017-1275
# of Openings
1
Category
Regulatory
Type
Full Time
Company
LFB USA

Overview

Oversee and direct all regulatory activities for LFB USA’s products, from preclinical research and development and the necessary statutory requirements pertaining to filings/registrations and ultimately approval as well as post-approval regulatory related activities. Responsible for the development of a regulatory strategy for the approval and commercialization of LFB USA’s products. Lead and manage a strong and diverse team within the regulatory department to achieve these goals. Responsible for developing and managing the US Regulatory Affairs budget.

Responsibilities

  • Develop and implement clear regulatory plans and pathway for LFB USA’s clinical programs as well as advise on the regulatory pathway related to manufacturing, product development, operations and testing programs.
  • Coordinate all aspects of regulatory filings and post-approval regulatory activities.
  • Provide guidance and advice to senior management and staff to achieve goals related to drug development and commercialization, including regulatory timelines, worldwide regulatory requirements, and also input and advise on chemistry, manufacturing and controls (CMC).
  • Develop and implement plans for the most efficient and timely submission and approval of regulatory filings.
  • Ensure compliance with FDA and EU regulations and guidelines related to regulatory strategy, submissions, product launch, labeling, advertising and promotion and reporting.
  • Represent LFB USA at FDA and EU governmental agencies as the regulatory lead to provide clinical and scientific information for product approvals.
  • Provide regulatory support to business development activities.
  • Responsible for long and short-term planning and directing of regulatory activities.
  • Oversee and manage a team of regulatory department professionals to work as one.
  • Develop and mentor junior regulatory associates and develop clear career paths.
  • Develop and oversee the regulatory department budget within the guidance and parameters developed by LFB USA Finance and Accounting.

Qualifications

Experience:

  • BS degree (MS preferred) and a minimum 10-15 years of leadership and regulatory experience in the biotech/pharmaceutical industry.
  • A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required.
  • A thorough knowledge and understanding of pharmaceutical manufacturing and regulatory requirements for drug approval is necessary.
  • Electronic regulatory submission proficiency with good computer skills and knowledge is essential for the compilation and filing of regulatory documentation.

 

Capabilities:

  • Requires a local as well as global (with our parent company in France) team and goal oriented individual to interact with the various functional groups.
  • Proven ability to lead and influence, in particular transversally. Build consensus; make clear recommendations to ensure key decisions are made timely.
  • Capability to anticipate critical issues and present mitigating options/actions.
  • Highly structured, organized management skills with excellent individual and group communication skills and ability to present to top management.
  • Strong attention to detail.
  • Travel < 20%.

 

 

 

 

 

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