Description

<h2>JOB DESCRIPTION:</h2><div>Core Job Responsibilities:Overall scope consists of providing operational support to EM Regional and Local Regulatory Teams, primarily in:Operational tasks in line with Abbott policies, procedures and local regulations<ul><li>Data management support into approved databases</li><li>Data entry into approved databases</li><li>Upload of data and documents into approved databases</li><li>Compliance check of documents to ensure data accuracy</li><li>Compilation suppo1t of data and documents into approved databases</li><li>Publishing support</li><li>Other administrative and operational tasks as per requirements</li></ul>Relationships & Cross Functional teamwork<ul><li>Interacts with relevant stakeholders to ensure effective communication and continuous Awareness</li><li>Ensures continuous alignment and timely delivery</li></ul>3. Coordination<ul><li>Demonstrates effective planning, follow up and co-ordination with relevant stakeholders</li><li>Provides timely and high-quality support as per internal procedure</li></ul>4. Compliance<ul><li>Ensures continuous compliance in alignment with Abbott procedures and regulations</li><li>Maintains awareness of legislation and implement changes as relevant</li><li>Ensure compliance with record retention (archiving) policy</li></ul>Process lmprovement<ul><li>Supports in streamlining and harmonizing relevant processes</li><li>Creates SOPs, delivers training as applicable</li><li>Identifies opportunities and suggestions for continuous improvements</li></ul></div>Position Accountability/Scope:Technical competency<ul><li>Demonstrates technical knowledge and good understanding of systems and tools</li><li>Shows general understanding of regulatory requirements Integrity</li><li>Delivers high quality results</li><li>Meets agreed deadlines</li><li>Displays consistency Adaptability</li><li>Shows flexibility and ability to work under pressure</li><li>Reacts quickly to solve problems and issues when they a1ise</li><li>Manages priorities and align with manager in case of conflicts/priorities Initiative</li><li>Attempts to anticipate, mitigate issues and proactively flag risks</li><li>Shows problem solving skills</li><li>Seeks for performance continuous improvements</li></ul>Minimum Education:Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related subjectMinimum Experience/Training Required:<ul><li>Minimum 2 years of relevant experience in regulatory operations</li><li>Detailed oriented, communication, compliance and process Improvement skills.</li><li>Computer Knowledge: .Knowledge of the Office package (Ms Word, Ms Excel, Ms Power</li></ul>     The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted. <h2>JOB FAMILY:</h2>Regulatory Operations     <h2>DIVISION:</h2>EPD Established Pharma        <h2>LOCATION:</h2>India > Mumbai : Mumbai Development Center - EPD     <h2>ADDITIONAL LOCATIONS:</h2>     <h2>WORK SHIFT:</h2>Standard     <h2>TRAVEL:</h2>Not specified     <h2>MEDICAL SURVEILLANCE:</h2>Not Applicable     <h2>SIGNIFICANT WORK ACTIVITIES:</h2>Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

EM Regulatory Operations Specialist

Description

Abbott

Pipeline