Regulatory Affairs Consultant

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