Cambrex High Point Regulatory Affairs Specialist in Charles City, Iowa
At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.
The Regulatory Affairs Specialist will be responsible writing, review and submitting submissions. Incumbent will be the primary FDA contact.
Write, review, compile and submit new Drug Master Files/CEP Common Technical Documents and their submission with the relevant Regulatory authorities.
Review, compile and submit amendments, updates and updates to existing DMFs for filing with the relevant Regulatory authorities.
Manage document and maintain all CCC regulatory filings with Health Authorities.
Serve as primary site liaison with Health Authorities concerning regulatory filings (i.e. issue LOA’s, responding to deficiency letters, requests for additional information).
Serve as a liaison with new and existing customers concerning regulatory filings (i.s. issuing CEPs, preparation and submission of Letters of Authorization, coordinate filings of EDMF/CDMF with MAA, communicate changes and proposed changes, coordinate responses to customer inquiries).
Obtain, maintain and manage site accreditation with foreign Health Authorities as Health Canada, TGA and PDMA (Japan).
Provide guidance and in-put to CCC project teams on regulatory requirements and guide compilation of DMFs/Registration Dossiers.
Review of various change controls for compliance to commitments made in Regulatory Submissions or requirements and complete assessments of regulatory impact.
Provide regulatory council on new and existing raw material, in-process and product specification and test methods.
Review of data received from R&D, manufacturing, analytical, supply chain and quality assurance departments.
5-10 years' of relevant industry experience.
Must have experience in Phamaceutical CDMO organization
Bachelor’s degree in a life science discipline, chemistry preferred
M. Pharm. or M.Sc../Ph. D. in Chemistry
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. (https://careers-cambrex.icims.com/jobs/1933/regulatory-affairs-specialist/job?mode=apply&apply=yes&in_iframe=1&hashed=-336240429)
Job LocationUS-IA-Charles City