Regulatory Affairs Coordinator: Strategic Product Submissions
hace 4 días
**Job Title:** Regulatory Affairs Coordinator: Strategic Product Submissions
About the Role:
We are seeking a highly skilled Regulatory Affairs Coordinator to join our team at Pfizer. As a key member of our regulatory department, you will play a crucial role in ensuring compliance with local regulations and facilitating business continuity.
Responsibilities:
You will be responsible for participating in the planning of regulatory strategies for product submissions and lifecycle, including APIs related to products under your responsibility. This will involve coordinating and executing activities related to dossier planning and submission, as well as clinical trial applications. You will also provide accurate and timely information about products under your responsibility and interact with internal stakeholders to ensure regulatory strategies are executed according to plan.
Qualifications:
To succeed in this role, you will need a degree in pharmacy or a life science, with a minimum of 3 years' experience in local regulatory affairs, preferably as a Regulatory Analyst (Human Medicinal Products). You should have knowledge of NCEs and biological products submission processes, CTAs applications, and product life cycle management activities.
Skill Requirements:
The ideal candidate will possess excellent communication and negotiation skills, problem-solving abilities, and proficiency in English. You should also have a strong understanding of local sanitary legislations and regulatory environments, as well as technical and scientific knowledge of human pharmaceutical products.
Estimated Salary Range: $60,000 - $80,000 per annum, depending on location and experience.
About Pfizer:
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, or disability.
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