Regulatory Affairs Manager 50% to pharmaceutical company

Presentation

As Regulatory Affairs Manager you will work with products in development phase as well as in life cycle management. You will be responsible for all regulatory submissions for a product portfolio for the Nordic markets and developing contacts with the Health Authorities across the Nordic region. The position offers many contacts internally within the Nordic Marketing Company as well as within the global functions in the company and with Health Authorities. The position is located in Södertälje, and the assignment is expected to last 50% for 6 months. There is a chance that the assignment will turn into a fulltime assignment during the fall.

Apply today as we will interview candidates continuously!


Arbetsuppgifter

As a regulatory manager you will be:
- responsible for regulatory submissions for a product portfolio supporting rapid and high quality approvals for marketing
- accountable for the regulatory compliance of our products with authorities and that the product information and labelling (SmPC, PIL, and artwork) are up-to-date. This work also includes translation into local languages.
- communicating with authorities on planned and pending items
- cooperating with functions within the marketing company as well as working cross functionally with the global teams in R&D, Operations etc.


Utbildning/erfarenhet

Minimum Qualifications
- masters degree in Pharmacy, Science or other related discipline.
- minimum 3-5 years experience within Regulatory Affairs and specifically experience within Nordic Regulatory Affairs.
- excellent verbal and written communication skills i.e. you must speak and write English and at least one of the Nordic languages fluently.
- a high degree of computer application literacy.
- demonstrated good organisation and planning skills in order to ensure prioritization of tasks.
- experience working with continuous improvements and lean philosophy is beneficial.
- demonstrated good organisation and planning skills in order to ensure prioritization of tasks.

In order to be successful in this role, you shall be structured and precise and have the ability to see the bigger picture and to identify business opportunities. You are able to act decisively, since many situations require effective decisions. As a team member, collaboration is a key factor - we are here to work together. Since the position requires frequent contacts internally as well as externally we see you being positive and able to establish fruitful relationships.

Förmåner

We take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment.

As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.

Företagsbeskrivning

Poolia Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.

Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.

Sluttext

Please apply by registering your CV here on our website. Click on the "Ansök" button to the right of this advertisement. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail adress is registered.

Poolia is a registered staffing agency, meaning that we comply with the requirements set by Bemanningsföretagen - the Swedish Association of Staffing Agencies.

Language

en-GB