Senior Regulatory Associate

hace 1 semana

Guadalajara, México Indegene A tiempo completo

**Date**:16 Apr 2025**Location**:Guadalajara, JAL, MX- Job Description-- Must Have- ob Description: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- 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- 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 request 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 organisation- 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 audience and methods to approach different deliverables- Volunteer in training programmes to develop skills in areas relevant to the job in addition to the areas of interestEDUCATION: BPharm / MPharm/ Pharm D/ MScEXPERIENCE: Required 4-6 years of experience in EU/ASEAN marketsLOCATION: Bangalore, Hyderabad (Office-based/Hybrid)- Good to have- EQUAL OPPORTUNITY

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