Regulatory Affairs Manager

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

Essential Functions

• Develop global regulatory CMC strategies to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which include CMC information
Write and compile CMC sections of regulatory submissions including clinical trial applications and variations/supplements as well as registration submissions worldwide
Lead team of SMEs through extensive knowledge of eCTD requirements for Quality modules with respect to marketing authorization, post approval changes and clinical trial applications globally
Review data provided to support dossier preparation; identify gaps and risks and work with stakeholders to understand regulatory impact of the risks identified to aid with mitigation and informed decision making
Manage answers to questions from the Health Authorities in a timely and effective manner to ensure early approval
Interact and negotiate with Health Authorities on CMC issues 
Develop and maintain project plans and schedules for CMC submissions
Evaluate proposed manufacturing changes for global impact assessments and provide regulatory strategies that support change implementation
Provide guidance on ICH, FDA, and EU CMC guidelines
Develop and maintain strong relationships with internal functional groups, contract manufacturing organizations and other relevant partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory objectives
Represent the Regulatory Affairs CMC function on assigned cross-functional project teams  
Ensure all CMC dossiers and relevant regulatory information are stored in Veeva according to Sobi's guidelines

Qualifications

• Bachelor's Degree Degree in Lifescience or related discipline Req Or

• Master's 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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more