Assistant Manager – Reg. Affairs 48 views

With 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 Lead Consultant, Regulatory Affairs-Submission Co-Ordinator.

Responsibilities:
Responsible to provide regulatory and administrative 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 overseeing submission activities.
Act as the single point of contact and communicate submission status to all stakeholders.
Create and maintain comprehensive project documentation, plans and reports.

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.
In depth working knowledge of industry standard systems and desktop applications including MS Word, Excel, and Adobe Acrobat Professional.
Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously.
Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables.
Demonstrates the ability to independently solve a range of straightforward problems that arise within job responsibilities and expectations.
Effectively communicates difficult issues both verbally and in writing, and persuades others in straightforward situations.
Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures.

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. ,

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