Lead Associate Regulatory Affairs
Job Description
With a start-up spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world\xe2\x80\x99s biggest brands\xe2\x80\x94and we have fun doing it. We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We\xe2\x80\x99re harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people. Now, we\xe2\x80\x99re calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing., People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower. Welcome to the relentless pursuit of better.
We are inviting applications for the role of Lead Associate, Regulatory Affairs
You will be responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies. You will also be responsible for the preparation and review of information required for development of regulatory CMC submission (i.e., US-Annual Reports).
Responsibilities:
Respond to health authority questions or local subsidiary requests for additional information to support the Annual Reports.
Administrative Content (Module 1) preparation for Annual Reports-US market.
To handle Regulatory document management systems: GCM-Trackwise, ORION -COGNOS, VEEVA, REDS, IPI etc.
Coordination with clients in tracking and status update of project plans.
Ensure a timely submission of Annual Reports as per the CMC content release date. Willing to work for US Shift.
Other skills we seek in you!
Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key partners.
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
Capability to prioritize multiple priorities and balance work to achieve business goals.
Demonstrated effective leadership, communication, and interpersonal skills.
Qualifications we seek in you!
Bachelor\xe2\x80\x99s degree preferably in Pharmacy, Biological Science, Chemistry, Nursing, or related discipline required with at least 4 years of related experience in the including research; manufacturing, testing, or licensure of pharmaceutical, vaccine, or biological products; or related fields. Alternatively, a master\xe2\x80\x99s or other advanced degree with relevant experience in pharmaceutical industry.
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 REDS or advanced document control system. Superior attentiveness to details.
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. Follow us on Twitter, Facebook, LinkedIn, and YouTube.
JobLead Associate Primary LocationIndia-Mumbai ScheduleFull-time Education LevelBachelor\'s / Graduation / Equivalent Job PostingApr 12, 2023, 1:56:28 AM Unposting DateOngoing Master Skills ListOperations Job CategoryFull Time
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Job Detail
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Job IdJD3056472
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationMumbai, Maharashtra, India
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EducationNot mentioned
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ExperienceYear