Lead Associate, CMC Regulatory affairs

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ 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 , CM C Regulatory affairs

Responsibilities

• Labelling variations: preparation of local documents, Cover Letter, electronical application form, update of German product information texts

• CMC variations: content check of documents provided by CMC ( e.g. Cover Letter, electronical application form); adding local information, update in Submission content plan

• Creation & maintenance of Veeva activities such as ROs, Submissions, Registrations etc in Veeva Vault before/after Submission/ Approval

• Maintaining the related trackers and update the information accordingly.

• Plan the due dates and coordinate the on-time delivery of the document, to meet regulatory submission timelines.

• Preparation and alignment of Product information texts with medical + PV + Information Officer

• Coordination of artwork implementation updates including annotations, proof-reading and approval (VISTA link)

• Coordination of purely national labelling variations and preparation

• Updates and upload of product information texts to Veeva Vault

• Coordination of RA activities (dispatched dossier (download the dossiers from Veeva and coordinate with partner/stake holders) including QC of the dossiers & compliance with local regulations + all Veeva management activities

• HA interaction + Post approval commitment + Regulatory intelligence coordination with Partners (distributors)

• Management and QC of regulatory data base (Veeva) and track the missing data in case needed including data remediation

• Business Project support RA feasibility and survey with Partner markets (Site transfers/ registrations, AW harmonization, etc.)

• AW coordination and Vista activities

• Provide accurate and timely regulatory CMC assessments for CMC changes.

• Provide CMC regulatory inputs to cross functional teams, recommendations.

• Coordinate and support dossier preparation, review in line with project timelines.

• Ensure high quality global fillings with timely approvals.

• Assure that for major CMC activities with a critical regulatory and/or financial, impact risks are identified and communicated.

Qualifications we seek in you

Minimum Qualifications

• Pharmaceutics, Chemistry, Biology (Master preferred)

• Required experience in CMC Regulatory.

Preferred Qualifications/ Skills

• Take the initiative, Interpersonal and communication skills

• English Fluency

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 .

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.