id: NDg4NDAzMSA3

reference: 4884031

documentId: 4884031

connectionPointId: 7

lastModificationDate: 1538045770263

stillingsbetegnelse: CMC Submission Specialist

jobbeskrivelse:

Zealand Pharma A/S (Zealand) is looking for an experienced CMC and Device Submission Specialist who in collaboration with CMC scientists will be responsible for the writing and reviewing of CMC submission documentation that lives up to Authorities’ expectations from a content perspective. You will be part of an innovative and agile Biotech company focused on the discovery, design, development and commercialization of innovative peptide-based medicines. You will be part of Commercial Manufacturing which is responsible for late-stage development and manufacturing activities. You will be working in a project team together with other development functions, and you will be working on several drug-device combination product submissions. Since Zealand is using Contract Development and Manufacturing Organizations, coordination and alignment with external partners are a key part of the job alongside internal Zealand collaboration.

 

Job Profile

The successful candidate will be responsible for the CMC and Device content of initial NDAs, during Q&A and subsequent lifecycle management activities:

 Drive the CMC and Device regulatory documentation gap analysis and plan mitigation strategies together with your regulatory affairs counterparts

 Coordinate CMC and device writing activities with several CMC scientists (API, DP, Device, Analytical and CMO Manufacturing)

 Be key writer to ensure content and storyline of the CMC and Device sections of submissions and authority questions/answers.

 

Candidate Profile

The successful candidate will have:

 A Life Science degree within chemistry, biochemistry, pharmaceutical sciences, or another relevant field

 10 years’ experience from the Pharmaceutical Industry

 Extensive experience with regulatory requirements for late stage CMC development and content of regulatory submissions (NDA/BLA/MAA)

 Hands-on technical writing experience from major regulatory submissions

 Experience with drug development processes

 Experience with contract development and manufacturing organizations

 Experience with participating in cross functional project teams

 Strong written communication skills in English

 Stakeholder management skills

 The ability and engagement to “walk the extra mile”

 Interest in working in a dynamic environment and taking on new challenges

 

What we offer

Zealand’s employees are one of the company’s most important assets. We strive to attract, develop and retain the best talents, and to be a company where every employee can thrive. At Zealand, we understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary and cross-cultural working environment. We offer a combined salary package including pension scheme and health insurance, as well as the option of joining the company lunch program, and use of massage, fitness and social facilities.

To find out more about working at Zealand, visit our careers site and view our company video at:

http://www.zealandpharma.com/zealand-as-a-work-place/

http://www.zealandpharma.com/video-about-zealand-new/

 

Application

Please send your application and CV no later than October 3, 1018 to:

career (at) zealandpharma.com

or

Zealand Pharma A/S

Att.: HR

Smedeland 36

DK-2600 Glostrup

For further information, please contact Vice President, Commercial Manufacturing, Jakob Gjelstrup Kristensen at +45 5060 3772 or jgk (at) zealandpharma.com

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2131

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: ZEALAND PHARMA A/S

source: DK-STAR