Summary :

- Manages, evaluates and completes international regulatory projects consistent with the company goals. Responsible for timely planning, coordination and submission of regulatory dossiers in non-US, non-EU regions (e.g., LATAM, APAC). Provides guidance to cross-functional teams on regulatory strategy and regional regulatory requirements.

Key Responsibilities :

- With minimal supervision, plan and manage regulatory activities related to assigned projects in non-US, non-EU regions as directed;

- Assist in developing and implementing strategies for the earliest possible approvals of regulatory submissions associated with assigned projects;

- Manage the assembly and timely submission of regulatory dossiers as required for clinical trials and registration of products in non-US, non-EU regions as directed;

- Serve as liaison with country managers and local regulatory consultants on regulatory matters;

- Prepare Requests for Proposal (RFPs) and help identify and select local regulatory consultants;

- Participate on project teams and provide expertise on international regulatory matters;

- Develop and maintain current regulatory knowledge in countries/regions of interest and advise management of significant developments;

- Review technical documentation and recommend/implement changes as appropriate to ensure regulatory compliance and conformances to existing regulatory approvals in ICH regions (e.g., life-cycle management).

Qualifications and Experience :

- Bachelor's degree or higher

- 6-8 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry

- Experience in orphan drugs desired

- Experience in preparation and submission of a full submission or large variation/supplement in at least one International region (e.g., LATAM, APAC) through to authorization

- Working knowledge of international (e.g., LATAM and APAC) regulations related to clinical trials and marketing applications in at least one International region; understanding of Competent Authority structure and function

- Experience with managing regional consultants

- Must have eCTD experience

- Proficiency with Microsoft Word desired

- Outstanding written and English verbal communication skills, Spanish written and verbal communication skills desired

- Outstanding interpersonal skills

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