Regulatory Affairs Manager

Overview

Individual contributor role acting as a Regulatory Team Leader on complex projects, with independent work under limited supervision.

What you'll do

• Act as a Regulatory Team Leader on complex projects, which may include technical writing, or as Project Manager for a stand-alone project, with guidance from senior staff as appropriate.
• Competently write regulatory and/or technical documents with minimal review by senior staff.
• Establish relationships with many customers, which may include face-to-face meetings to discuss regulatory issues and present lessons learned; adopt a proactive and flexible approach to resolve issues.
• Undertake detailed review and management of project budgets, including out-of-scope activities; ensure revenue is recognised and challenge when appropriate.
• Give guidance to junior colleagues, including feedback on the quality of technical documents, and assist in their training and development.
• May present to clients at bid defense meetings by phone or in person for a range of regulatory deliverables, at the discretion of senior staff.
• May write new regulatory standard operating procedures, propose revisions, or act as reviewer for regulatory standard operating procedures, as assigned.
• May be involved in a Regulatory and/or IQVIA Initiative, and may support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative.
• May manage meetings with Regulatory Agencies.
• May be assigned as Reviewer and/or Approver for regulatory or cross-functional standard operating procedures owned by other operations.
• Perform other tasks, assignments and duties as delegated by Regulatory management or as business needs require.

What you'll need

• Bachelor's Degree in Life Science or related discipline, or Master's Degree in Life Science or related discipline.
• At least 8 years relevant experience.
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate.
• Specific regulatory or technical expertise, with sufficient knowledge of managing regulatory projects and deliverables in a time-bound manner.
• Expert in planning and delivering work on time while keeping quality parameters in mind.
• Knowledge of regulatory procedures in the appropriate region, particularly marketing authorization transfers and relevant cross-functional dependencies.
• Good working knowledge of regional regulatory intelligence.
• Ability to work closely with client regional heads to determine the MAT, Regulatory Publishing and submission strategy and execute the marketing authorization transfer plan, if applicable.
• Good understanding of pharmacovigilance activities relevant to transfer of marketing authorization.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable.
• Ability to work on several projects, with direction from senior staff as appropriate, and to follow standard operating procedures consistently.
• Experience of involvement in regulatory strategy and determination of documentation requirements, timelines and budgets for MATs and publishing projects.
• Project leadership experience.
• Ability to adapt quickly to a rapidly changing environment.
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies.

Details

• Location: Bangalore, India.