Regulatory Affairs Specialist

MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

Job Specific Skill Requirements

• Leads in the preparation of regulatory documents, including Module 1 content.
• Prepares and reviews the documentation required for standard HA interactions (deferrals, extensions, proposals, etc) with stakeholder input.
• Leads technical preparations for HA meetings, including review and/or creation of supporting forms and documentation.
• Leads cross-functional review of documents/deliverables to ensure compliance with the requirements set by HAs.
• Tracks the status of applications under regulatory review and provides updates to stakeholders.
• Maintains a current knowledge of regulations and guidance as they pertain to developmental focus (ie, a single region and/or developmental phase).
• Develops robust knowledge of eCTD requirements and related project plans/document inventories.
• As requested, finds information and/or potential answers to challenging areas related to assigned projects.
• Provides strategic input for development of targeted literature search protocols.
• Conducts thorough self-review of deliverables prior to release to client.
• Supports the development of internal RA systems, procedures, tools, and training.
• May serve as Regulatory Point of Contact and archives and maintains all communications according to MMS and Sponsor SOPs.

Competencies for Level I and II Roles

• Level of Independence:
  • Level I: Task and project level focus. Receives a moderate level of guidance and direction. Requires support and guidance from the LM or Sr. Team Member approximately 25% of the time or more
  • Level II: Developing understanding of the Service Management process requirements. Identifies and suggests opportunities for improvement related to Service and/or Service Line at the project level.
• Service Management:
  • Developing understanding of the Service Management process requirements. Identifies and suggests opportunities for improvement related to Service and/or Service Line at the project level.
• Customer Liaison/ Management:
  • Interaction with the external and internal customer at the project level. Some oversight and guidance from a more senior colleague or Manager regarding best approaches with customer communication may be required.
• Impact:
  • Project level impact. Has a working knowledge and experience in own discipline. Project level impact. Applies acquired job skills, policies, and procedures to complete substantive assignments/projects/tasks of moderate scope and complexity; exercises judgment within defined guidelines and practices to determine appropriate action.
• Innovation/ Continuous Improvement:
  • Uses existing procedures to solve routine or standard problems. Contributes to process improvement.
• Discretion/ Latitude:
  • Exercises discretion related to communication with the customer. With some guidance from more senior team member or a manager able to exercise proper judgement related to disclosure of information based on appropriate audience.
• Problem Solving:
  • Uses existing procedures to solve routine or standard problems and may contribute to solving unique challenges.
• Communication:
  • Effectively communicates with the project team members internally and externally.
• Quality and Quantity of Work:
  • Produces high quality project deliverables with minimum corrections oversight or course correcting from Line Manager or a more senior colleague.

Core Company Values

• Represent self and company in a professional manner and in line with core company values.
• Practice excellent internal and external customer service, communication, and team work.
• Support objectives and improvement efforts within department and organizationally.
• Comply with all applicable policies, procedures, and training requirements.
• Additional tasks as assigned by manager.

Requirements

• College graduate in scientific, medical, clinical discipline or related field, or related experience, Regulatory Affairs Certification (RAC) or other post-academic professional credential for regulatory professionals preferred.
• Minimum of 3 years’ experience in Regulatory Affairs or similar field required.
• Expert knowledge of scientific principles and concepts.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Excellent problem-solving skills and willingness to work with others to clearly understand needs and solve problems.
• Good organizational and communication skills.
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.

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