Senior Manager-Regulatory Affairs
Senior Manager-Regulatory Affairs
Posted on :
06-04-2025
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1 Vacancy
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Job Description
Inviting applications for the role of Senior Manager Regulatory Affairs Consumer CMC for Global market.
In this role candidate should have experience in regulatory affairs (team handling experience) while essential exposure lifecycle document management (LCM). Need to have good knowledge of ICH guidelines and postapproval submissions and regulations.
Responsibilities
The Role demands expertise with demonstrating ability to execute responsibility in a highly regulated & process driven environment the Person will be responsible for all the activities related to following things:
1. Responsible for overseeing the project progress managing the team ensuring the project stays on schedule and maintaining communication with stakeholders.
2. Responsible for implementing CMC regulatory strategies for assigned consumer products in accordance with global regulations guidance and defined regulatory strategies.
3. Responsible for the writing of CMC quality documents for the dossier and/or the entire module 3 from raw data quality control of the CMC documents ensuring the project meets the goals and standards.
4. Review and evaluation of existing quality documentation and assessment of required updates during Project Renewals.
5. Preparation of Quality Overall Summaries (QOS) for drug product and drug substance.
6. Compilation of dossiers for launch applications for marketing authorization and new drug applications in Global markets.
7. Submission of relevant sections in Annual Reports for US Market.
8. Preparing RA expert response for deficiency letters from various regulatory authorities.
9. Assessment of registration documentation for consumer products as per the current Health Authority requirements.
10. Knowledge of review and assessment of manufacturing analytical validation and stability documents.
11. Postapproval submission knowledge for EU markets.
Qualifications we seek in you!
Minimum Qualifications / Skills
Bachelors degree preferably in Pharmacy Medicine Chemistry or related Life science discipline required with relevant experience in the pharmaceutical industry.
Mandatory Knowledge of ICH and FDA guideline for global market market.
Advanced tableau/power bi knowledge needed.
Analyzing and mining business data to identify correlations and discover patterns from various data points.
Should be advance level in English language.
Preferred Qualifications/ Skills
Facilitate effective communication and collaboration among team members. Provide guidance support and mentorship to team members.
Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission.
Ability to identify problems and work with team to formulate a potential course of action.
Effective time management and organizational skills to efficiently manage multiple timesensitive assignments simultaneously.
Demonstrates deep understanding of the business value of quality and compliance and the implications and risks of noncompliance. Adjusts behaviors to drive high quality deliverables.
Must demonstrate oral and written communication skills and the ability to communicate issues in a succinct and logical manner.
Demonstrates the ability to independently solve trouble problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions.
Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.
Flexibility to adapt to a changing environment keeping current with new and updated processes and procedures.
Depending on experience level mentor newly hired staff or lead a team of junior staff.
Flexibility in responding to changing priorities or dealing with unexpected events.
Capability to handle multiple priorities and balance work to achieve business goals.
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 www.genpact . 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:
Senior Manager
Employment Type
Full-Time
Key Skills
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