Arbejde Manager – Regulatory Affairs CMC Hovedstaden SYMPHOGEN A/S - jobtilbud

GÆLDER
stillingsbetegnelse: Manager – Regulatory Affairs CMC

jobbeskrivelse:
This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for clinical portfolio, which consists of monoclonal antibodies and monoclonal antibody mixtures. This position will provide input into the product strategy and to the direction provided to the clinical teams. Incumbent will be responsible for assuring the established regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality. Provide support for other CMC projects as needed. Experience working in a matrix environment and excellent people skills are required. Additional duties include coordination with our core teams and assisting in other regulatory affairs activities within the company as well as assisting in European regulatory activities for all programs as needed. Major Activities/Key Responsibilities • New applications for biologics o Plan/Prep/Submit/Review support for product dossiers o CTA / IND preparation and maintenance • License Maintenance o Recurrent filings: annual reports • Regulatory Submissions o Regulatory strategy development o Preparing / Authoring / Review of Submissions o Technical Review of site supporting documents for regulatory submissions (CoA, declarations, SMF, MBR, SOPs) o Notify Vendors/ CROs for publishing o Response to Queries from Health Authorities • Change Controls o Change control assessments o Initiate change in regulatory database and ensuring regulatory submissions are completed as required • Provide interpretive analyses regarding impact of complex regulatory guidance documents, regulations, or directives that impact company products and operations. Required Qualifications • University degree in scientific discipline with at least 5 years of total regulatory experience and at least 3 years of regulatory CMC experience • Knowledge of FDA and EMA regulations is essential. • Experience with IND and CTA applications. • Experience with biological products • Strong communication and language skills, written and verbal (Danish/English) • Self-driven, highly motivated, team player with commitment, initiative and humor Preferred Qualifications • Proficient in MS Word, Excel, and PowerPoint • Excellent organizational and communication (written and verbal) skills. • Demonstrated ability to work successfully on project teams. • Experience with both BLA and MAA applications • Experience in within the oncology/hematology disease area • Previous experience working in a fast paced environment on multiple product lines • Manufacturing, QA/QC experience We offer • A challenging and versatile job in an innovative, flexible, focused and committed biotech environment • Competitive salary based on qualifications • Compensation package including a personalized and company-wide bonus system, flexible working hours and an inspiring working environment Working in Symphogen When being a part of Symphogen you will always have a challenging job in a creative, goal-oriented, value-based biotech environment with a meaningful mission. You will be a part of a highly engaged organization with a passion of being the worldwide leading recombinant polyclonal antibody company. You will have good development opportunities, in an organization that is inspiring and growing, with focus on diversity, teamwork, commitment and you as a person. For further information For more information you are welcome to contact Meghan Brown, Head of Regulatory Affairs at mebr (at) symphogen.com or HR-Director, Lisbet Løschenkohl at +45 4526 5050. Please also see http://www.symphogen.com for information about our company. If you are interested in the position, please mark your application and CV – Manger Regulatory Affairs and mail it to: job (at) symphogen.com no later than September 15, 2016. Potential candidates will be invited for interview as they apply and we reserve the right

Arbejdsgiver Navn: SYMPHOGEN A/S

Arbejdsgiver telefonnummer: 45265050

Sådan ansøger: job (at) symphogen.com

Job kort beskrivelse:
Andet ingeniørarbejde (undtagen elektroteknologi)

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark

GÆLDER

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