Job title: Global Regulatory Professional
Company: General Electric
Job description: Job Description Summary As a Global Regulatory Affairs professional with expertise within Regulatory Affairs marketed products you will be supporting Marketing Authorisation activities from a full lifecycle management perspective, offering technical
Job Description Summary As a Global Regulatory Affairs professional with expertise within Regulatory Affairs marketed products you will be supporting Marketing Authorisation activities from a full lifecycle management perspective, offering technical expertise and obtaining relevant approvals where required. You will be responsible for providing support to regulatory submissions in an efficient and timely manner through cross collaboration with multiple stakeholders and uphold ‘right first time’ submission quality and timeliness. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Roles and Responsibilities In this role you will: Interpret regulations, guidelines and requirement and act as a Regulatory expert responsible for complete lifecycle management of submissions MAA – Marketing Authorization Application (various European procedures, ROW – Rest of the World, MAAs), Renewals (Europe and Non-Europe) and variations (RA – Regulatory Activities such as Safety updates, Labelling updates, administrative updates. & Quality variations) starting from strategic discussions with cross-functional teams (internal & third party), preparation of packages in line with regulations, coordinating with the CMC – Chemistry Manufacturing Control team to get CMC documentation and also with the publishing team to get the output ready as per market need, dispatch to markets, follow-up submissions until made and track until approval. Work closely with line manager and Global Regulatory product leads (GRPL), as directed, to ensure that submission strategies are executed as per HA requirements to achieve efficient positive outcomes. Be responsible for ensuring information relating to allocated submissions is uploaded into the Regulatory information management database as per the standard documented procedures. Ensure that relevant KPIs within the lifecycle of regulatory submissions, as defined in standard procedures, are met. Work with cross functional teams such as GRPL/CMC/National Regulatory Affairs/Publishing/Pharmacovigilance, Clinical, Non-clinical/Manufacturing Site(s), as needed, to plan and execute regulatory submissions. Participate in projects related to improving the processes, standards, and learning sharing. Escalate issues/risk to regulatory submissions at the right time with sufficient information. Support global regulatory or technical initiatives or act as a representative on behalf of regulatory team, as needed. Write or review regulatory standard operating procedures or cross functional procedures, as needed. Required Qualifications Bachelor’s degree in life sciences or related discipline 7 plus years of extensive Regulatory Affairs experience is essential in pharmaceutical or radiopharmaceuticals domain, with knowledge of regulatory requirements in major regions (Europe, United States, and Rest of the World) both in CMC and RA submissions Adept at Regulatory strategy and/or submission execution Expert in planning and delivering work on time keeping first time quality in mind Hands-on experience with Regulatory information management systems (e.g., Veeva Vault) Hands-on experience in artwork management systems is preferred Ability to work effectively without direct supervision Willing to travel when required, but not more than 5-10% Desired Characteristics Strong interpersonal skills and ability to engage effectively with colleagues at all levels Ability to resolve day-to-day issues, escalating issues that impact strategic initiatives Experience working with outsource partners an advantage Inclusion and Diversity GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust lead with transparency deliver with focus, and drive ownership – always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. #LI-MA3
Location: Gurgaon, Haryana
Job date: Fri, 22 Jul 2022 22:51:21 GMT
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