regulatory affairs manager in Monthey

posted
contact
Jirel Kuenen, 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
16719
contact
jirel kuenen, 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 experience in 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 as well as regulatory activities of chemical pharmaceutical drug products under development.

 

Key Responsibilities :

- Maintenance of registration files 

- Coordinate with partners’ regional regulatory teams for global strategy 

- Define, develop and lead regulatory strategies for post-marketing and clinical development activities 

- Maintenance and update of the Product Information 

- Prepare and review regulatory submissions 

- Manage CMC activities for products under development 

- 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 regulatory activities for Chemical Pharmaceutical Drug Products under development (phase 1 to phase 3) 

- 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 

 

If you recognise yourself in this job description, do not wait any longer and apply directly!