Regulatory Affairs Consultant
Bengaluru, India Job ID R0000025182 Category Regulatory / Consulting Date Posted 08/26/2024Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
Regulatory Affairs Consultant:
- Around 7-10 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologicals) in various markets.
- Good understanding of regulatory framework, including regional trends, for various types of applications and procedures
- Lead and / or contribute to the planning, preparation, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.
- Responsible for managing (Authoring and Review) of biologics/biosimilar/vaccine investigational product submission such as IND & IMPD for USFDA, EMA
- Authoring, review, and submission of BLA/MAA dossiers for US/EU/ROW /India markets
- BLA authoring and also post approval submissions for Biosimilar.
- Preparation of regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, CTA, BMF, BLA, NDA, and MAA applications.
- Life cycle management (LCM) for approved products. (annual reports, variations, renewals) for Europe (Type IA/IB/II/IAIN)
- Evaluation of change controls and deviations and defining regulatory strategy
- Preparation and submission of scientific advice, briefing book, Type 2 meeting packages for USFDA and EMA
- Co-ordination with internal and external stake holders for documentation required for filing. Identify quality and/or timeliness issues with source documents, as early as possible
- Develop up-to-date knowledge about regulatory guidelines and applies regulatory requirements and their impact on submissions.
- Working experience in Regulatory Information Management Systems like Veeva Vault.
- Strong communications skills and ability to guide and mentor team members.
- Ability to work independently.
PAREXEL-related Activities:
- Meets established metrics as specified in scorecard on an annual basis
- Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, training compliance, project deliverable archiving, participation in internal initiatives/projects as requested by management
- Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)
Skills:
- Project management knowledge
- Client-focused approach to work
- Results orientation
- Teamwork and collaboration skills
- Excellent interpersonal and intercultural communication skills, both written and verbal
- Critical thinking and problem-solving skills
- Proficiency in local language and extensive working knowledge of the English language
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