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Job Description
Be actively involved in the development and life-cycle management of medicinal products thereby contributing to appropriateness of the drug development path as well as to compliance with applicable pharmaceutical legislation / regulation. And assist the local regulatory lead in preparation and execution of regulatory strategies and to manage the submission and approval of applications for marketing applications or other related regulatory submissions.
Your Role
- Providing support to regulatory related timely submissions and registration maintenance, other activities assigned as appropriate.
- For projects assigned, develop and provide input to the development of sound regulatory strategies and properly execute them.
- Elaborates risk mitigation plans that support the company's portfolio. Critically review regulatory submissions for portfolio and countries assigned.
- Act as functional expert on local/regional/global project teams for projects and countries assigned, interpreting issues and provide
strategic input to project team on the application of local regulations, review processes and submission requirements.
- Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.
- Provide input to critical submission documents and agency responses throughout the product lifecycle to ensure that they support local requirements of all countries assigned.
- Develop and manages optimal labeling for all products, countries assigned throughout the product lifecycle in close alignment global labeling group and meeting corporate labeling standards.
- Ensure review and release of promotional material according to local regulations and corporate policies and procedures for portfolio and countries under responsibility.
- Establish and maintain excellent working relationships with review staff of local health authority where applicable, and other local regulatory agencies, as required
Who You Are
- Minimum of 5 years relevant work experience in RA field
- Experience with assisting in the preparation and writing regulatory documentation to support agency interactions
- Demonstrated knowledge in NDA / CTD requirements
- Bachelor's Degree in Pharmacy preferred or other Science degree
- Good interpersonal skills
- High Attention to detail
- Ability to work in teams
- Strong organizational and planning skills
- Advanced skills for standard MS office
