Regulatory Affairs Senior Manager

Start Date: when possible

End date: permanent position

Department: Regulatory Affairs

Reporting to: Senior Director Regulatory Affairs

Place of Work: Chemin du Pre-Fleuri 3, Plan-les-Ouates, Geneva, 1228 Switzerland

PregLem is a specialty biopharmaceutical company focused on developing and commercializing a portfolio of innovative products addressing significant benign gynecological conditions and infertility. PregLem is a member of the Gedeon Richter group.

The successful candidate will manage regulatory activities for the on-going registration and post-registration activities of PGL4001 in selected markets (EMA and Swissmedic). In addition, the role offers regulatory development activities for a compound in clinical development and US Regulatory exposure.

KEY POSITION RESPONSIBILITIES

• Coordinate electronic compilation, review and approval process of regulatory documentation for submission to Regulatory Authorities (with the help of eCTD service provider).
• Manage these submission processes, in close coordination with PregLem's respective departments and the consultants which are involved, within the foreseen timelines
• Identify issues that may delay submission and recommend appropriate action to be taken
• Be the regulatory affairs representative in the project team for assigned development compound
• Follow the regulatory activities performed in conjunction with the US partner

EXPERIENCE

• At least 8 years of experience in regulatory in the pharmaceutical/biotech industry, including regulatory submissions within Europe
• Excellent understanding of post- registration processes (variations) in the EU, including centralised procedure
• Experience in development (CTA, meeting with HAs, development plan, etc...)
• Knowledge of eCTD
• Knowledge of document management and electronic publishing systems is a strong plus
• Experience in Regulatory CMC is a plus
• Strong general technology skills and ability is required
• Strong project and submission management is required
• A demonstrated ability to effectively manage relationships with both inside and outside the organisation
• Ability to work effectively through cross-functional team to achieve results

SKILLS

• Flexibility, ability to handle time pressures and work to a prescribed schedule
• Ability to work in a fast pace change-oriented environment
• Ability to work in a matrix organisation
• Team player, team leader, strong interpersonal skills, strong communication skills
• Strong scientific skills, ethics and creativity
• Sets priorities consistent with company goals and focus on high-priorities projects

Should your profile match the above requirements, we would be glad to receive your application in English.

In line with its culture, PregLem SA is committed to insuring full confidentiality in the treatment of all received data.

CONTACT:

Diane Gillieron

Human Resource Manager

Diane.gillieron@preglem.com

PregLem SA.

Only applications meeting the required profile will be considered.

PregLem S.A.

Chemin de Pre-Fleuri

1228 Plan-les Ouates

T: +41 (0)22 884 03 40

F: +41 (0)22 884 03 49

www.preglem.com

e-Marketing Manager

Start Date: 1st January 2012

End Date: permanent position

Department: Marketing

Reporting to: Head of Marketing

Place of Work: Chemin du Pre-Fleuri 3, Plan-les-Ouates, Geneva, 1228 Switzerland

PregLem is a specialty biopharmaceutical company focused on developing and commercializing a portfolio of innovative products addressing significant benign gynaecological conditions and infertility. PregLem is a member of the Gedeon Richter group.

KEY RESPONSABILITIES

The Marketing Manager e-Marketing will focus on the development and implementation of the Esmya international digital marketing tactics and strategies.  

• Develop, plan, implement and supervise e-Marketing programs to support the launch of Esmya in Europe (on line marketing tactics and media, social media strategies, multi-media channels and digital detailing)
• Identify key components of the marketing mix to be leveraged in digital marketing communication
• Provide support to the marketing team for identifying key marketing mix components to be leveraged in digital marketing communication  and in line with global Esmya brand strategies
• Contribute to marketing communications including branding, public relations, advertising and sales materials
• Maintain close contacts with global marketing, medical marketing, affiliates, clinical and regulatory
• Help identify revenue opportunities, allocate appropriate resources, manage budgets and prioritize programs
• Develop digital marketing initiatives in line with local and international regulatory requirements

JOB REQUIREMENTS

• Scientific and/or business degree
• At least 5 to 8 years of both local and international marketing experience (e-marketing projects) in the pharmaceutical/biotechnology industry
• Additional Pharma Communication and PR experience is a plus
• Solid expertise and background in Digital marketing including experience with multi-media channels, social media, digital doctor and patient communication strategies
• Experience in new product launch
• Strong oral, written and presentation skills
• Creative eye together with strong attention to detail
• Candidate should be a dynamic, results oriented, team player and able to work independently in a "start-up" environment
• Complete fluency in English is a must. French is a plus
• Willingness to travel (20%)

Should your profile match the above requirements, we would be glad to receive your application in English.

In line with its culture, PregLem SA is committed to insuring full confidentiality in the treatment of all received data.

CONTACT:

Diane Gillieron

Human Resource Manager

Diane.gillieron@preglem.com

PregLem SA

Only applications meeting the required profile will be considered.

PregLem S.A.

Chemin de Pre-Fleuri 3

1228 Plan-les Ouates

T: +41 (0)22 884 03 40

F: +41 (0)22 884 03 49

www.preglem.com