stillingsbetegnelse: Regulatory Affairs Manager

jobbeskrivelse:

Antibody therapeutics is currently the fastest growing business in the pharmaceutical industry. Following the historical success of monoclonal antibodies, Symphogen is striving to develop and commercialize superior antibody mixtures based on the diversity of the natural human immune system by use of Symphogen's proprietary technology suite. Symphogen A/S has built an innovative oncology pipeline consisting of mAbs and mAb mixtures, and performs activities from early discovery to mid-stage clinical development, which translates into new and challenging opportunities for our organization and employees. Symphogen is located in Ballerup in the greater Copenhagen area.

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

- Plan/Prep/Submit/Review support for product dossiers

- CTA / IND preparation and maintenance

- License Maintenance

- Recurrent filings: annual reports

- Regulatory Submissions

- Regulatory strategy development

- Preparing / Authoring / Review of Submissions

- Technical Review of site supporting documents for regulatory submissions (CoA, declarations, SMF, MBR, SOPs)

- otify Vendors/ CROs for publishing

- Response to Queries from Health Authorities

- Change Controls

- Change control assessments

- 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

Desirable requirements:

- 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

Place of work: Ballerup, Denmark

Timer per uge: Permanent, 37,5 Hours per week

Arbejdsgiver Navn: Symphogen A/S

Arbejdsgiver adresse: Pederstrupvej 93 2750 BALLERUP

Form af kontakt:
HR Coordinator Pia Holm Olesen +4588382512 e-post: pho (at) symphogen.com

Arbejdsgiver telefonnummer: +4545265050

Job kort beskrivelse:
Arbejde inden for biologi, botanik, zoologi og beslægtede områder

land: Danmark

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Erfaringer: Se fritekst

Kilde til jobtilbud:
Arbetsförmedlingen, Offentlige arbejdsformidlinger, Sverige

Kørekort: Nej

Hvordan søger: Andet - se fritekst