Plan, organize, and prepare documents and regulatory submissions for domestic and international product development and registration.


Major Duties and Responsibilities:

1. Ensure timely preparation of organized and scientifically valid regulatory submissions, including but not limited to IND/IMPD/NDA/BLA/MAA to appropriate health authorities to meet regulatory requirements.
2. Work with management to develop, plan, organize and implement regulatory strategy.
3. Participate in product development teams/project teams to assure timely, smooth, and efficient development of regulatory submissions for clinical trials and product registration.
4. Provide regulatory guidance to functional area to ensure understanding, rapid and effective development of regulatory document requirements needed for timely submissions.
5. Interface with regulatory agencies.
6. Remain current with all regulatory requirements and standards necessary to develop and obtain licensure for company as oncology products.
7. Ensure corporate and partner adherence to and compliance with established company quality policies, practices, SOP's, and applicable US, EU and ROW regulations.


Requirements .
Experience: Minimum of 5 years regulatory experience in the Pharmaceutical/Biotech Industry. Must have knowledge and understanding of US and international laws, regulations, and guidelines pertaining to new drug development and registration. Must have successful experience in preparation of Investigational Application in CTD format.

Job Complexity: Works on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Supervision: Manages and coordinates regulatory projects, works independently with minimum supervision. Will hire and supervise associate when scope of project requires.

Education: BS/MS in a scientific discipline or equivalent experience.

If you are interested in this position, apply online at www.medimmune.appone.com and search for Req 00860.

MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.

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