regulatory affairs manager in Monthey

posted
contact
Angèle Atlan, Geneva Professionals Health Care & Life Sciences
job type
permanent
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job details

posted
location
monthey, vaud
sector
life sciences
job type
permanent
reference number
15450
contact
angèle atlan, geneva professionals health care & life sciences
phone
058 201 54 40

job description

Are you looking for your next role within Regulatory Affairs? Do you have a significant experience in sterile parenteral chemical drugs?

In this case you should have a look at this opportunity!

Our client, a private, Swiss-based biopharmaceutical company, mainly focused in oncology and bacterial infections, is looking for their next: 

REGULATORY AFFAIRS MANAGER, 100% - permanent role

(Valais canton - Monthey area)

Mission :Manage post marketing regulatory activities of drug products including extension of indications.

Key Responsibilities :

- Maintenance of registration files Asean and Middle East countries

- Maintenance of API DMF

- Prepare registration files for new territories in Middle East and Asean countries

- Coordinate with partners’ regional regulatory teams for global strategy

- Define, develop and lead regulatory strategies for assigned territories

- Maintenance and update of the Product Information

- Prepare and review regulatory submissions

- Internal Regulatory contact for Pharmacovigilance and Marketing and Business

- Maintain policy & regulatory intelligence

- Provide regulatory strategies for projects as RA representative in cross-functional teams

Your profile :

- Degree in Science (e.g. Chemistry, Pharmacy) or equivalent

- 5 years’ experience in Pharmaceutical regulatory affairs for sterile parenteral chemical drugs, ideally prolonged-release formulation

- Experience in preparation and maintenance for DMF for chemical API

- Experience with Chinese Authorities

- Maintenance, Renewal, Extension of indications

- Previous experience in meeting with Health agencies

- Fluent in French and English

- Strong attention to details and organizational skills required

- Good written and oral communication, technical writing and editing skills

Your future: 

- The opportunity to join a pharmaceutical company in full expansion

- The possibility to work on project management

- Flexible working hours

 

If you recognize yourself in this job description, do not wait any longer and apply directly!This ad was posted by Angèle, your Senior Recruiter from Randstad Geneva.Do you want to know more about her? Take a look at her video introduction by clicking here.