Job Title : Lead Consultant – Regulatory Affairs-LIF007298

Location : India-Mumbai

Lead Consultant – Regulatory Affairs-LIF007298With a start-up 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.

Inviting applications for the role of Lead Consultant, Regulatory Affairs for Consumer CMC for Global Markets

GRA complete spectrum of regulatory and compliance services include compliance evaluation, critical issue remediation and resolution, risk assessment analysis, supporting system design and deployment, gap analysis, pharmacovigilance and Publishing. Driving transformation and improving regulatory compliance with domain expertise and digital technology.

Candidate should have profound experience in regulatory affairs with must expertise in regulatory affairs for Pharmaceutical or Biotech industry, lifecycle document management. Also need to have good knowledge of ICH guidelines and post-approval submissions and regulations.

Responsibilities

In this role, you will be responsible for:

Consumer CMC:

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.
Post-approval submission knowledge for EU markets

Additional:

Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission
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 trouble shoot 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.

Qualification

Minimum Qualification

B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy

Preferred Qualification

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 decision-making, 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.

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.
 

 
 Job Lead ConsultantPrimary Location India-MumbaiSchedule Full-timeEducation Level Bachelor’s / Graduation / EquivalentJob Posting Apr 22, 2022, 1:09:38 PMUnposting Date OngoingMaster Skills List OperationsJob Category Full Time