@ MacroGenics
  • Post Date : Jan 10, 2022
  • Apply Before : Mar 22, 2022
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Job Description

Summary of Position:

The Vice President of Regulatory Affairs will be responsible for developing the global regulatory strategy for development-stage programs including CMC, regulatory submissions, regulatory compliance, regulatory advice and counseling, advertising and promotion review, and product registrations across the product portfolio as well as lifecycle of all products, assuring they are in compliance with health authorities.  An integral part of this role is to continue to build strong relationships and advocacy with the FDA – both at the local and national level – as well as with notified bodies and international regulatory authorities.  He/she will ensure strong coordination and collaboration with other leaders within the organization, including clinical, commercial, operations, product development, quality, compliance and legal, and will be responsible for developing regulatory capabilities within the company, including the hiring and management of appropriate team members.

Responsibilities and Job Duties:

  • Manages and leads the Regulatory Affairs function to ensure compliance with applicable rules and regulations while creating competitive advantages in the market for MacroGenics. Provide regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment, and regulatory precedent.
  • Collaborates with Development, Clinical, Business Development, Operations and Senior Management to develop regulatory strategies at all stages of drug development. Implements and oversees regulatory strategy and activities needed to secure new indications for existing pipeline assets, approval of new drugs, and commercial products. Provides guidance on regulatory mechanisms to optimize product development.
  • Provides strategic leadership on all regulatory activities in support of any drug development work that includes NMEs, new indications for existing products and any Life Cycle Management work. Manages coordination, preparation and timely submission of regulatory documents. Ensures project teams prepare high quality international and domestic filings/registrations and responses to Agency requests within established timelines.
  • Oversees the review and/or management of regulatory reporting activities, including but not limited to: Annual Reports, drug safety updates, post-approval manufacturing changes, stability updates, review submission packages, labeling revisions, or promotional materials for compliance with global regulations, as needed; recommend appropriate changes.
  • Serves as primary liaison with regulatory authorities, including overseeing the writing of pre-meeting briefing materials, leading the preparation for meetings and facilitating sponsor interactions with regulators, and ensuring appropriate follow-up.
  • Develops and maintains strong working relationships with external legal and regulatory consultants to assist MacroGenics in its relationships with regulatory agencies. Assures that the FDA perceives a consistent and high-quality approach in submissions and compliance. Further, ensures that all necessary regulatory advice and information is available to MacroGenics through internal knowledge or appropriate consultants.
  • Provides expertise in translating regulatory requirements into practical, workable procedures and plans.
  • Provides guidance regarding evolving practices and requirements to facilitate effective product development and approval efforts.
  • Leads and manages constructive interactions with project team members, consultants, contractors, and regulatory agencies to ensure all project/programs have clearly defined regulatory paths and milestones leading to successful filings and approvals.
  • Works closely with Quality Assurance to develop and implement SOPs, as appropriate, and monitor product-related activities for regulatory compliance.
  • Develops and designs best-in-class regulatory structures, processes and procedures based on expert understanding, industry experience and insight into future direction. Ensures that the regulatory function possesses the knowledge, experience, and talent to ensure the company can meet world-class standards. Provides leadership in building the regulatory infrastructure, including developing and leading a future staff of regulatory professionals.
  • Provides regulatory leadership for due diligence activities, partnering activities, and product/company integrations.
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