We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com

What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it?

We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.

We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you.

If this excites you, then apply below.

Job Description:

ROLE PURPOSE: Manage a team; direct, develop and review various regulatory deliverables & dossiers; ensure quality as per set HA standards.
SKILLS:
• Dossier Preparation (eCTD, ACTD and CTD)
• Good communication skills (Written and Oral)
• MS Office (Excel and Power point), Adobe Professional
• Desirable to have hands on experience on RIMS preferably Veeva Vault, Trackwise
PRINCIPAL RESPONSIBILITIES:
• Thorough knowledge of EU, MENA and ASEAN markets country requirements/regulatory affairs procedures for initial submission, licensing, post-approval submission management
• Solid project management, organizational and time management skills to manage
• Client-specific project delivery process
• Strong analytical skills and problem-solving skills
• Excellent knowledge on various regulatory guidelines related to Dossier Preparation & Regulatory Submission for EU, MENA and ASEAN markets in ACTD, eCTD and non-eCTD format [e.g., NDA/BLA/INDs, MAAs]
• Provides guidance to project teams related to worldwide HA submission structure/format/requirements, submission filing strategy, eCTD document lifecycle management and submission compilation workflows
• Co-ordinate with relevant cross functional group Regulatory Affairs, CMC, Submission Managers and Medical Writing to obtain accurate, appropriate information for regulatory submission
• Develops, completes, and maintains submission delivery plans, submission content plans, and proactively provides status updates to designated collaborators.
• Assist in the preparation and submission of post-approval regulatory filings, variations, and renewal applications
• Review regulatory dossier preparation and submission like new drug application, variations, renewals, site registration etc.
• Conduct gap analysis to identify compliance issues and implement corrective actions to align with regulatory requirements.
• Review the content prepared by junior team members. Validate the authenticity of the content by performing QC of the dossier prepared
• Responsible for high client satisfaction for all regulatory submission deliverables with regard to quality and accuracy, timelines, and efforts
• Performing RCA when required with the team and preparing CAPA
• Prepare the company for regulatory inspections and audits, including mock audits and readiness assessments.
• Conducting regular client calls for content-related discussions as well as for project status updates and delivery
• Participate in trainings and learn through hands-on experience on the job
• Participate in client-specific training if applicable
• Mentoring of new joiners with respect to SOPs and processes
• Understand various target audience and methods to approach different deliverables

EDUCATION: BPharm / MPharm/ Pharm D/ MSc

EXPERIENCE: Required 6-8 years of experience in EU, MENA and ASEAN markets

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.