Regulatory Associate

1 week ago

Bengaluru, India Indegene Full time

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 Indegene’s high-speed growth.

We are purpose-driven.
** **We enable healthcare organizations 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.

Experience with global regulatory submission formats and ACTD/eCTD/ /NeeS/Paper dossiers format, including familiarity with submission publishing activities is required.

PRINCIPAL RESPONSIBILITIES & ACCOUNTABILITIES:

- Basic medical/pharma/scientific knowledge that can be applied in developing regulatory submission documents
- Thorough knowledge of major HA global/regional/national country requirements/regulatory affairs procedures for initial submission, licensing, post approval submission management
- Markets Handled: Australia, Cambodia, Hong Kong, Korea, Malaysia, Macao, Indonesia, Pakistan, Philippines, Singapore, Taiwan Thailand, Vietnam
- Prepare and compile global regulatory dossiers in ACTD, eCTD and non eCTD format in accordance with ASEAN HA legislations and client specific requirements
- Prioritise, plan, and monitor submissions for allocated products while documenting and informing involved parties of progress
- Able to support and prepare Module 1 documents - submission form, cover letter, notification forms, comparison tables for regulatory submission
- Hands-on experience on regulatory document management systems and publishing tools
- Able to create submission packages in line with regulatory strategy for pharmaceutical drugs, vaccines, generics, GMO’s, and biological products
- Coordinate with cross-functional teams, including R&D, quality assurance, and manufacturing, to gather necessary information and documentation for dossier preparation
- Regular tracking and maintaining the submission trackers
- Stay updated with evolving regulatory requirements and industry trends and able to extract regulatory intelligence information (requirements for initial filing, drug/device/cosmetic/food registration etc.)
- Participate in trainings and learn through hands-on experience on the job
- Exhibit flexibility in moving across new projects and preparing multiple document types
- Continuously enhance and maintain knowledge of various regulatory guidelines for different deliverables by doing various assignments
- Volunteer in training programs to develop skills in areas relevant to the job in addition to the areas of interest

EDUCATION: BPharm / MPharm/ Pharm D/ MSc

EXPERIENCE: Required 2-4 years of experience in ASEAN markets

LOCATION: Bangalore, Hyderabad (Office-based/Hybrid)

**EQUAL OPPORTUNITY**

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.

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