| Job Description – Associate – Regulatory Affairs (LIF007392)|
Associate Regulatory Affairs-LIF007392With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it.
Come, transform with us. Are you the one we are looking for?
We are inviting applications for the role of Associate, Document Specialist – Regulatory Affairs.
• Responsible to provide regulatory filing support for assigned Submissions by:
o Handling required submission activities (planning, obtaining required data (CMC/ancillary documents), coordination, reviewing, and release) in accordance to regulatory requirements and project timelines
o Responding to health authority questions or local subsidiary requests for additional information to support the Submission
• Responsible to provide support for tracking regulatory submission documents.
• Work closely with various stakeholders to ensure timely follow-ups and receipt of documents for compiling submission packages in electronic/hardcopy format.
• Collaborative interaction to ensure quality, right first-time output and timeliness.
• Monitor document availability status and escalate delays to avoid risk(s).
• Setting-up and coordinating meetings and managing submission activities. Qualifications we seek in you!
• Bachelor’s degree, preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline required with relevant experience in the pharmaceutical industry. Alternatively, a Master’s or other advanced degree, preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline required with relevant experience in pharmaceutical industry.
• Project Management expertise
• Understanding of regulatory requirements
• Excellent organizational skills and a proven ability to multi-task
• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
• Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
• Demonstrated proficiency in advanced document management system.
• Superior attentiveness to detail.
• Ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
• Flexibility in responding to changing priorities or dealing with unexpected events.
• Capability to handle multiple priorities and balance work to achieve business goals.
• Effective leadership, communication, and interpersonal skills.
• Ability to prioritize tasks to meet deadlines and collaborate with a team when help is needed.
• Ability to identify problems and work with team to formulate a potential course of action
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws.
Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com.