Manager CMC, Regulatory Affairs
Camurus AB / Kemistjobb / Lund
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Position summary
The Manager CMC, Regulatory Affairs will be responsible for developing, coordinating, and supporting the CMC aspects of regulatory submissions to global Health Authorities for development products and in support of marketed product registrations.
This position will require close interaction with management from multiple internal functional areas, collaboration partners, international regulators and external experts and consultants.
The primary duties and responsibilities include:
Leading and implementing regional and/or global CMC submission activities, including planning, writing, review, coordination and submission of CMC sections of Briefing Packages, meeting requests, INDs, NDAs, CTAs, MAAs and other regulatory filings for assigned development projects and marketed products.
Assessing proposed CMC strategies, determining regulatory implications, and assuring appropriate actions are taken to ensure regulatory compliance.
Keeping abreast of changes in regulatory requirements and ensuring that appropriate actions are taken to comply with regulatory changes.
Building and maintaining positive relationships internally and with regulatory agencies.
Assessing data provided for HA submissions against regulatory requirements.
Ensuring records of filings and approvals are maintained.
Participate in HA meetings as required.
Provide support in developing CMC regulatory strategies for the registration of products that are aligned with Company business strategy and target time lines.
Qualifications required
The candidate must possess an advanced degree in sciences (MSc required) with 5 years or more of experience in pharmaceutical industry. The ideal candidate will have strong experience in Regulatory CMC, and preferably also Pharmaceutical Development experience.
He/she must be detail oriented with excellent interpersonal, teamwork and verbal/written communication skills. Good organizational skills and the ability to manage multiple tasks/projects/priorities and complex systems simultaneously will be needed.
The candidate must have working knowledge/experience in regulatory submissions and approval processes for Pharmaceuticals and ability to deal with complex CMC regulatory issues and requirements.
Ability to work independently on researching regulatory information and making assessment of relevance of regulatory information on submissions is essential to the position.
For further information, please contact Markus Johnsson
markus.johnsson@camurus.comphone: +46 (0)46 286 5745
Please send your application sent to
job@camurus.com , before October 15, 2012.
Publiceringsdatum2012-09-17Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast lön
Så ansöker duAnsökan kan skickas till e-postadress:
job@camurus.comKontaktMarkus Johnsson, Senior Director, 046-2865745
FöretagCAMURUS AB
AdressCAMURUS AB
FORSKNINGSBYN IDEON
22370 LUND
KontorsadressSÖLVEGATAN 41
LUND
Övriga kontaktuppgifterTelefonnummer: 046-2865730
Jobbnummer 1341912
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