Regulatory Affairs Manager

IQVIA Biotech; Bengaluru; Presencial; INR 1 500 000 - 2 300 000; Tempo integral

Resumo da oferta

IQVIA Biotech in Bengaluru seeks an experienced Regulatory Team Leader. An individual contributor role with advanced knowledge, works independently under limited supervision on complex regulatory projects.

You will lead regulatory writing, manage budgets, interact with clients, guide junior staff, and help develop SOPs and regulatory strategies. Requires 8+ years of Lifesciences regulatory experience and strong collaboration across functions.

Qualificações

• Bachelor's degree in Lifescience or related discipline required.
• Master's degree in Lifescience or related discipline.
• At least 8 years relevant experience.
• Understanding of R&D process and regulatory guidelines.
• Regulatory or technical expertise with project management.
• Ability to plan and deliver work on time with quality.
• Knowledge of regional regulatory procedures, MATs and publishing.
• Experience in regulatory strategy and documentation timelines.
• Project leadership experience.

Responsabilidades

• Act as Regulatory Team Leader on complex projects with guidance.
• Competently write regulatory and technical documents with minimal review.
• Build relationships with customers and discuss regulatory issues face to face.
• Manage project budgets and ensure revenue recognition.
• Guide junior colleagues and provide training and feedback.
• Present to clients at bid defense meetings by phone or in person.
• Write or review regulatory SOPs and propose revisions.
• May be involved in Regulatory or IQVIA initiatives.
• Perform other tasks as delegated by Regulatory management.
• May manage meetings with Regulatory Agencies.
• May serve as Reviewer/Approver for regulatory SOPs.
• Support global regulatory or cross-functional initiatives.
• Perform other duties as required.

Conhecimentos

Project leadership

Regulatory expertise

Budget management

Regulatory publishing

Cross-functional collaboration

Documentation writing

Regulatory strategy

Stakeholder management

Microsoft Office

Formação académica

Bachelor's degree in Lifescience

Master's degree in Lifescience

Descrição da oferta de emprego

Job Summary

Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline. Works independently under limited supervision.

Responsibilities

• Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand‑alone project, with guidance from senior staff as appropriate;
• Competently writes regulatory and/or technical documents with minimal review by senior staff;
• Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues;
• Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate;
• May give guidance to junior colleagues, including feedback on the quality of technical documents, and may 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 discretion of senior staff;
• May write new regulatory standard operating procedures, and/or propose revisions and/or act as reviewer for regulatory standard operating procedures, as assigned and appropriate.
• May be involved in a Regulatory and/or IQVIA Initiative;
• Performs other tasks or assignments, as delegated by Regulatory management;
• May manage meetings with Regulatory Agencies;
• May be assigned as Reviewer and/or Approver for Regulatory standard operating porcedures or cross-functional standard operating porcedures owned by other operations;
• May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative;
• Performs other duties, as business needs require;

Qualifications

• Bachelors Degree Degree in Lifescience or related discipline Req Or
• Masters Degree Degree in Lifescience 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;
• Possesses a specific regulatory or technical expertise. Sufficient knowledge of managing regulatory projects, project deliverables on a time bound manner;
• Expert in planning and delivering work on time keeping quality parameter in mind;
• Knowledge of regulatory procedures in 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 submission strategy and execute 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;
• Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements;
• Ability to make decisions on discrete tasks under senior supervision;
• Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
• Experience of involvement in regulatory strategy and determination of documentation requirements, timelines, budgets for MATs, Publishing projects;
• Project leadership experience;
• Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
• Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
• Ability to adapt quickly to a rapidly changing environment;
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies