Pharma Regulatory Associate Job at Indegene – Apply Online
Pharma Regulatory Associate Job at Indegene – Apply Online.Interested and eligible applicants can check out all of the details on the same below:
Title: Senior Regulatory Associate
Date: 2 Aug 2024
Location: Bangalore, KA, IN
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 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: 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 PowerPoint), 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, 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
- Reviews the content prepared by junior team members. Validates the authenticity of the content by performing QC of the dossier prepared
- Coordinates 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 the 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
- Ensures submission/query/additional requests by HA are communicated to 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
- Exhibits flexibility in moving across new projects and preparation of multiple document types
- Continuously enhances and maintains knowledge of various writing guidelines for different deliverables by doing various assignments
- Understands various target audiences and methods to approach different deliverables
- Volunteers 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)
If this excites you, then apply here.
Keywords: Senior Regulatory Associate, Healthcare Solutions, Global Growth Opportunities, Entrepreneurial Organization, Regulatory Dossiers, EU Markets, ASEAN Markets, Regulatory Affairs, Career Growth, Healthcare Technology, Fast-Track Careers, Leadership Development, Rapidly Growing Organization, Communication Skills, Regulatory Submission Formats, Regulatory Intelligence, Regulatory Document Management Systems, Regulatory Risks, Regulatory Compliance, Healthcare Industry. Pharma Regulatory Associate Job at Indegene – Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
