Regulatory Affairs Manager (BLA exp)

Location: Gaithersburg, Maryland Salary: competitive
Sector: Pharma & Biotech Type: Contract

Title: Regulatory Affairs Manager

Location: Maryland (Onsite)

Rate: To be discussed

Length: 1-3 Months (FTE or extension possible)

Summary of Position

This position will be managing the regulatory aspects of one or more Company projects. This individual will work closely with senior Regulatory Affairs staff and/or cross functional team members (eg, Research, Clinical, Project Management) to develop submission timelines, outlines, and/or strategies. This position will have a variety of responsibilities to include preparation of regulatory documents, reviewing for regulatory compliance and monitoring of new guidances from various regulatory agencies.

Responsibilities and Job Duties:

  • Managing the regulatory activities for assigned projects; therapeutic areas include oncology and autoimmune disorders
  • Working with the Director, Regulatory Affairs to design and implement global regulatory development strategies
  • Interacting with Research, Clinical, Project Management and other staff contributing to a submission regarding content and timelines; ensuring sections provided to Regulatory are consistent with internal submission format standards; reformat sections as necessary
  • Preparing and assisting in the preparation of high quality domestic and international regulatory submissions (e.g., IND (e.g., Initial IND, Briefing documents, Annual Reports and other maintenance submissions), IMPD, CTA, BLA/MAA)
  • Serving as a primary Regulatory representative on project teams by providing regulatory input and strategy
  • Interacting with FDA and other Regulatory Authorities on assigned projects as appropriate
  • Reviewing new regulatory guidances and other similar information, evaluating its potential impact on projects, and advising personnel from other departments regarding applicability and impact
  • Providing regulatory research on new products and interacting cross-functionally to develop innovative strategies on new products
  • Generating Regulatory SOPs with input from stakeholders; providing training where appropriate
  • Continuing professional development by attending regulatory-related meetings, (e.g., FDA Advisory Committee meetings, conferences, workshops)
  • Performing regulatory research tasks or scientific-based projects as requested
  • Providing support to senior Regulatory Affairs staff as requested


Education & Experience

  • Bachelor's degree in scientific discipline; advanced degree desirable
  • Minimum of 5 years of Regulatory Affairs experience

Knowledge, Skills and Abilities

  • Knowledgeable regarding FDA regulations and guidances as well as international regulatory guidances and requirements (e.g., ICH)
  • Demonstrated experience resolving domestic and international regulatory issues
  • Detail-oriented with ability to work effectively both independently and on a team
  • Ability to coordinate information from various internal and external sources
  • Excellent organizational skills with the ability to multi-task on several projects
  • Excellent verbal and written communication skills including ability to discuss technical information and regulatory requirements with project teams and FDA
  • Highly flexible, adaptable and accustomed to working in a fast-paced environment

Supervisory Responsibilities


Preferred Skills

  • Preference for previous experience with oncology drug development
  • Expertise in MS Office; experience with Electronic Document Management Systems for preparing and finalizing regulatory submissions preferred

Sthree US is acting as an Employment Business in relation to this vacancy.