We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent thats 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.Looking to jump-start your career?We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegenes high-speed growth.We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.
Must Have
:
ROLE PURPOSE:
Candidate will be responsible for preparing and managing regulatory dossiers, coordinating with regulatory authorities for EU and ASEAN markets and providing guidance on regulatory requirements to internal teams.
Skills
- 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 & ASEAN markets - country requirements/regulatory affairs procedures for initial submission, licensing, post-approval submission management
- Experience with global regulatory submission formats, including familiarity with submission publishing activities
- Organizes, leads, and facilitates and or participates in cross-functional meetings with stakeholders
- Understands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across EU & ASEAN markets
- Leads and/or contributes to the planning, preparation (including authoring where relevant), and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
- Hands-on experience on regulatory document management systems and publishing tools
- Able to support and prepare Module 1 documents - submission form, cover letter, notification forms, comparison tables for regulatory submission
- Uses and shares best practices when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment
- Review the content prepared by junior team members. Validate the authenticity of the content by performing QC of the dossier prepared
- Coordinate with cross-functional teams, including R&D, quality assurance, and manufacturing, to gather necessary information and documentation for dossier preparation
- Tracks timely delivery of submission components, coordinates submission publishing activities with publishing team and organizes internal review and approvals.
- Tracking and maintaining the submission trackers
- Identifies regulatory risks and proposes mitigations to Lead and cross-functional teams
- Ensure submission/query/additional requests by HA should be communicated to the global colleagues through agreed process
- Able to extract regulatory intelligence information (requirements for CTA, drug/device/cosmetic/food registration etc.)
- Provides coaching, mentoring, and knowledge sharing within the regulatory organization
- Mentoring of new joiners with respect to SOPs and processes
- Exhibit flexibility in moving across new projects and preparation of multiple document types
- Continuously enhance and maintain knowledge of various writing guidelines for different deliverables by doing various assignments
- Understand various target audiences and methods to approach different deliverables
- Volunteer in training programs to develop skills in areas relevant to the job in addition to areas of interest
EDUCATION:
BPharm / MPharm/ Pharm D/ MSc
Experience
Required 4-6 years of experience in EU/ASEAN markets
LOCATION:
Bangalore, Hyderabad (Office-based/Hybrid)
Good to have
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, the candidates 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.
Locations
Bangalore, KA, IN
