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Senior Regulatory Affairs SME (EU Regulations Medical & Pharmaceutical)DallasTexas.

Senior Regulatory Affairs SME (EU Regulations Medical & Pharmaceutical)

Dallas | Texas | United States

Job Title:
Senior Regulatory Affairs SME (EU Regulations Medical & Pharmaceutical)

Type of Position:

Job Location:
Irving, TX (Relocation Assistance Available)


Available (very competitive)

Job Description:
HRU Technical Resources has partnered with a leading chemical and advanced materials company to place a Senior Regulatory Affairs SME (EU Regulations Medical & Pharmaceutical).  This person will:
This person will:
•    Serve as the SME for EU regulations in medical / pharmaceutical / healthcare applications
•    Lead Product Risk Management Reviews
•    Assist customers with regulatory submissions
•    Manage correspondence with regulatory agencies, especially in the EU

Required Knowledge / Skills / Abilities:
•    Strong understanding of EU regulatory framework for medical and pharmaceutical chemical manufacture
•    Proficiency in conducting and documenting regulatory product risk assessments
•    Good understanding of GMP and quality principles as they apply to the medical and pharmaceutical product manufacture
•    Familiarity with US and EU medical device and drug development process (MDD, MDR, 510K, IND, NDA, ANDA)
•    Familiarity with MAF, DMF and eCTD format required
•    Ability to interpret regulations and translate regulatory requirements into compliance strategies
•    Project Management experience; candidates will initially have 3-4 projects going at a time, but as things grow will need to take on more

Desired Knowledge / Skills / Abilities:
•    Ability to manage multiple projects in a fast-paced environment
•    Ability to effectively oversee projects outsourced to consultants/laboratories

Required Years of Experience:
•    Minimum 3 years regulatory / product stewardship experience in medical or pharmaceutical area.
•    5 to 7 years preferred

Education Requirements:
Bachelor of Science in Chemistry, Biological or Life Sciences (biochemistry, toxicology, etc.)

Work Environment / Other Info:
1st shift (day) position, office environment

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