id: MDIyMDE5MDYwMDAwMTEgMjYx

reference: 02201906000011

documentId: 02201906000011

connectionPointId: 261

Stillingstittel:
Regulatory Affairs Manager, Regulatory Affairs & Pharmacovigilance Department

Stillingsbeskrivelse:

For Us, It's A Mission

At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world's 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what's right, not what's easy. If you are a doer and have a passion for serving others, we want to talk to you.

Make a Difference

At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role.

Overall Job Purpose:

Drive the company's visions and goals by the excellent management of regulatory activities for the product portfolio. Ensure new marketing authorizations are approved and maintain and optimize the existing registrations in line with regulatory requirements.

Main Accountabilities:

· Responsible for the fulfilment of regulatory requirements for new Marketing Authorisation Applications and Post-Approval Activities for regionally supported products.

· Timely coordinate, prepare and submit regulatory applications, renewals, variations, MA withdrawals to relevant markets in cooperation with other functions. Ensure safety updates are submitted in a timely manner.

· Responsible for preparing product information, approve artwork, coordination of co-packs and timely implementation

· Assess, approve, progress and ensure timely implementation of change controls

· Ensure regulatory execution excellence of product launches in close collaboration with internal stakeholders (as assigned)

· Support the Dormant Dossier process, RMS transfers, and sunset clause monitoring.

· Support the organisation in order to comply with food supplement regulation (as assigned)

· Support the organisation in order to comply with medical device regulation (as assigned)

· Operate in compliance with company processes, SOPs and guidelines.

· Other duties as assigned

Make Our Values Your Values

Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care.

The Regulatory Affairs Manager must be able to cooperate successfully across all functions of the organization, and to represent the company externally in the best possible way. Further, qualified candidates possess the below qualifications:

Professional skills:

· Formal education at MSc level (pharmacy or other relevant subject within Life Sciences)

· At least one to two years of work experience within the pharmaceutical industry and/or Health Authorities in the field of regulatory affairs

· A strong knowledge of the European and the Norwegian regulatory requirements and guidelines

· Able to operate internationally with fluent English and Norwegian

Personal profile:

· Strong interpersonal skills -- robust with natural authority, easy going

· Works well in teams and alone

· Service minded; a 'doer' -- getting things done, also when the pressure is high

· Has eyes for details

· Ability to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity

· Analytical and systematic

ATTRACTIVENESS OF THE COMPANY & POSITION

· An exciting and challenging position where the candidate will secure deliverables on time in high quality.

· Mylan is growing, developing speedily -- room for making business and success

· Opportunities to develop professionally as well as personally.

· An international and highly dynamic environment, including collaboration with international colleagues and external partners.

Currently this is a one year temporary position, but the position might turn permanent.

Interested or any questions?

Please contact Head of Regulatory Affairs, Peter Boros by phone +47 45 07 33 80 or mail peter.boros (at) mylan.com

Deadline to apply for the position is June 17th, but applicants will be evaluated consecutively.

Se annonse

PAM

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2262

abstractJV_contact_0: See jobabstractJV_description

contractTypeCodes_0: fulltime

Arbeidsgiver Navn: MYLAN HEALTHCARE NORGE AS

source: NAV