Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post: Regulatory Affairs - CMC Roles
Job Discription:
Life Cycle Management(injectables & Solid Orals-Regulated Markets)
Experienced in developing strategy, compilation review & submission of post-approval Changes (Supplements/variations) to Global Health Authorities
Biosimilars
Experienced In developing strategy & compilation, review & submission of Biosimilars registration dossiers & post-approval changes to Global Health Authorities.
API - DMFs(US & EU)
Experienced in compilation, review & submission of API DMFs and extensive experience in handling post filing changes including change control review and DMF Life Cycle Management
Candidate Profile:
Master Degree in Pharmacy / Science/ Ph. D
3 to 15 years of pharmaceutical or Biotech experience in RA function for major Markets like US. Europe, Canada, ROW Regions:
Excellent Communication skills: Sound Regulatory Knowledge
WORK LOCATIONS: HOSPIRA SITES - HOSPIRA SITES IN CHENNAI (DRUG PRODUCT)/ AURANGABAD (API)
Hyderabad on 29th and 30th July 2017
Trident Hyderabad HITEC City,
Madhapur Hyderabad, Telangana - 500081
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