Regulatory Affairs Consultant
Bengaluru, Karnataka, India 求人ID R0000025182 Category Regulatory / ConsultingAbout 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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