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DG - Lead Consultant - Regulatory Affairs

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.

Transformation happens here. Come, be a part of our exciting journey!

Are you the one we are looking for?

Inviting applications for the role of Lead Consultant, Regulatory Affairs!

In this role, we are looking for associate with good knowledge of ICH guidelines and Post-approval submissions and regulations

Responsibilities

  • · Dossiers preparation
  • · Artwork updates- Liasing and coordinating with Labelling teams, supply and Quality. Proactive with Batch launching and delivery updates.
  • · Post-approval regulations
  • · Post-approval submission knowledge for EU markets
  • · Knowledge of manufacturing documents like batch records, specifications, analytical methods, validation reports, stability data.
  • · Developing and writing clear explanations and justifications for any new change or update in the dossier
  • · Demonstrating leadership in departmental improvement activities such as system modifications, maintenance of standard operating procedures, internal guidelines, etc.
  • · Demonstrating an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
  • · Managing & executing of CMC documentation including variations and responses to health authority questions per established business processes and systems

Qualifications we seek in you!

Minimum Qualifications

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

· Advance Verbal and Written communication skills.

· Experienced user of MS office.

· Team Player

· Providing Coaching to enhance performance of Team member.

· Proactive approach & Taking initiatives.

· Ability to provide solutions for client documents.

Preferred Qualifications / Skills

· Enthusiasm & confidence

· Adhere to our principles and values

· Time Management skills

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 Consultant

Job ID: LIF005597

Primary Location: India - Mumbai

Education Level: Bachelor's / Graduation / Equivalent

Job Posting: Jul 26, 2021

Master Skills List: Operations

Job Category: Full Time