Lead Associate-Regulatory Affairs
Lead Associate-Regulatory Affairs
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Job Description
Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125000 people across 30 countries are driven by our innate curiosity entrepreneurial agility and desire to create lasting value for clients. Powered by our purpose the relentless pursuit of a world that works better for people we serve and transform leading enterprises including the Fortune Global 500 with our deep business and industry knowledge digital operations services and expertise in data technology and AI.
Inviting applications for the role of Lead Associate Regulatory Affairs for Consumer CMC for Global Markets
In this role Candidate should have experience in regulatory affairs while essential exposure to the lifecycle document management (LCM) and also need to have good knowledge of ICH guideline and FDA guideline for Global market. In depth working knowledge of ICH / IND /EU/NPD Annual report and CMC variations. US FDA post approval submissions and expertise in designing regulatory strategy and decision with respect to CMC filing.
Responsibilities
Responsible for implementing CMC regulatory strategies for assigned consumer products in accordance with global regulations guidances and defined regulatory strategies.
Responsible for the writing of CMC quality documents for the dossier and/or the entire module 3 from raw data.
Review and evaluation of existing quality documentation and assessment of required updates during Project Renewals.
Preparation of Quality Overall Summaries (QOS);
Compilation of dossiers for launch applications for marketing authorization and new drug applications in Global markets.
Submission of relevant sections in Annual Reports for US Market.
Preparing RA expert response for deficiency letters from various regulatory authorities;
Assessment of registration documentation for consumer products as per the current Health Authority requirements.
Knowledge of review and assessment of manufacturing analytical validation and stability documents.
Postapproval submission knowledge for EU markets
Qualifications we seek in you!
Minimum Qualifications
/ / B. Pharmacy / M. Pharmacy
Preferred Qualifications/ Skills
Expertise in VeevaVault will be a plus point.
Ability to prioritize tasks to meet deadlines and work with team when help is needed.
Ability to identify problems and work with team to formulate a potential course of action.
Must demonstrate oral and written communication skills and the ability to communicate issues in a succinct and logical manner.
Overall candidate should have decisionmaking research and analytics approach and in numbers.
Capability to handle multiple priorities and balance work to achieve business goals.
Good people and customer handling skills
Effective leadership communication and interpersonal skills.
Adhere to our principles and values.
Effective time management and organizational skills to efficiently manage multiple timesensitive assignments simultaneously.
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 respect and integrity customer focus and innovation. For more information visit . Follow us on Twitter Facebook LinkedIn and YouTube.
Furthermore please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a starter kit paying to apply or purchasing equipment or training.
Required Experience:
IC
Employment Type
Full-Time
