Job title: Lead Consultant, Pharma Regulatory Affairs
Job description: 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, Pharma Regulatory Affairs
· Dossiers preparation in CTD modules & submission
· Post-approval regulations
· Artwork updates- Liaising and coordinating with Labelling teams, supply and Quality. Proactive with Batch launching and delivery updates.
· Responsible for review and update of artwork if required
· 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
· Depending on experience level, mentor newly hired staff or lead a team of junior staff.
· Responsible for the preparation and review of the information required for the development of regulatory CMC
· Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems
Qualifications we seek in you!
- B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy
- Excellent Verbal and Written communication skills
- Ability to transfer knowledge
- Ability to engage with people immediately & build Relationship
- Team Management skills and proficiency
- Good client communication
- Basic project management skills
- Mentoring junior team members
- Good at problem-solving & Decision Making
- Enthusiasm & confidence
- Adhere to our principles and values
- Time Management skills
- Organizational 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.
Location: Mumbai, Maharashtra
Job date: Sun, 13 Mar 2022 05:41:40 GMT
Apply for the job now!