Job Description

Looking for a versatile, exciting, and critical position where you will be the overall responsible for keeping the \xe2\x80\x9cLicense to Operate\xe2\x80\x9d for Ferring in Sweden? We are seeking a highly skilled and motivated individual to join us as Regulatory Manager for Ferring Sweden, who will be working within the Nordic Regulatory team and in close collaboration with other Nordic teams such as marketing and medical, as well as with global teams.

Please email us your application and attach your CV by clicking the Apply button below.

Areas of responsibility
Regulatory Affairs

Apply for and maintain (variations, renewals, etc.) marketing authorizations, incl. product texts and labelling

Maintain regulatory files

Maintain Swedish product information databases (internal and external - eg. Fass.se and VARA etc.).

Pharmacovigilance

Fulfill the responsibilities of Local Safety Officer in Sweden, i.e., receive, process, report, follow-up and archive safety information from the local market, literature, studies, contractual partners and competent authorities.

Quality Assurance

Fulfill the requirement of Responsible Pharmacist/Person in Sweden (HSLF-FS 2021 :95)

Ensure implementation and maintenance of a quality system
Make appropriate notifications to relevant bodies, e.g., in out-of-stock situations, recall situations, suspected falsifications etc.

Carry out self-inspections

Handle deviations, customer complaints, product defects and recalls

Initiate, update, review and approve GDP critical Technical Agreements with third-party contractors suppliers and distributors.

Compliance

Internal approval of promotional materials and projects for the Swedish market according to legal and ethical requirements.

Requirements

As Regulatory affairs Manager you either need to be a pharmacist or have worked in that position before. Minimum 3-5 years working experience.

Experience within the Pharmaceutical industry

Experience with LIF (L\xc3\xa4kemedelsindustrif\xc3\xb6reningen)

Experience with Swedish Medical Products Agency (L\xc3\xa4kemedelsverket)

Fluent in both Swedish and English

Meriting

Experience working with Pharmacovigilance Experience working with quality assurance Experience working with Compliance

Personal characteristics

Problem-solving and solution oriented

Organized and have strong prioritization skills

Strong stakeholder management skills

You work well independently and are also a strong team player with high ethical standards

Professional and trustworthy

Good communications skills

About Ferring
At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women\'s health, gastroenterology, and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world.Every person at Ferring works together to change lives and help people build families. Our corporate teams offer empowering, innovative, challenging and rewarding careers - we are motivated to make a difference. To reach our full potential we collaborate, and respect and value diverse contributions so that we can grow as an organization and as professionals. Together we can influence the world around us to make life and work better.

Please email us your application and attach your CV by clicking the Apply button below.

Location:
Malm\xc3\xb6, Sweden

Ref no:
A037727

Application deadline:
6th of July

Melissa Minaya

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