Regulatory Affairs Manager

Gerresheimer Boleslawiec SA is a member of the International Gerresheimer Group, which specializes in manufacturing high quality packaging and application systems for pharmaceutical and packaging for the cosmetics industry. In Poland it is the largest and most versatile manufacturer within the industry.
Currently, our team is looking for a candidate for the position:

Regulatory Affairs Manager
Workplace: Bolesławiec/ Wrocław/ Dresden
Ref. No. :  1/1022/2012

Responsibilities:

• Product registrations for all BU in GPP
• Advice the organisation in development in new requirements within regulatory affairs
• Evaluate the regulatory needs for new business areas for management decisions
• Participate in specific projects: customer projects, new applications etc.
• Be the experts to advise others in specific regulatory issues
• Establish and maintain knowledge of customers registration process and need for documentation in relation to GPP products
• Support sales / customers in product registration
• Influence on the development of regulatory requirements in EU
• Establish matrix over drug group/GPP packaging
• Develop registration strategy which create biggest barrier of entry for competitors

Tasks :

• Facilitate new product registrations
• Source, evaluate and negotiate with registration companies
• Maintenance of existing product registrations
• Annual update of DMF to FDA
• Optimisation of product registration process
• Establish and maintain an overview of current international regulatory requirements in GPP Library
• Support internal and external (customers) needs in relation to regulatory issues
• Ensure that all comparison memos include all relevant regulatory information
• Perform training of relevant persons in relation to regulatory issues
• Support the development of product database to ensure that standard product specifications supports all needs in relation to customers product registration
• Define USP & EP tests for standard products
• Give comments to new and proposal for update of directives, standards and norms in EU
• Evaluate the need of request and prepare relevant compliance statements to customers with defined approval
• Establish and maintain minimum requirements for compliance for raw materials depending on the application
• Evaluate compliance for new materials and consequences for updated compliance statements for existing materials
• Participate in discussions with suppliers in relation to R&A issues
• Implementation of migration calculation model for food approval
• Specific migration limits
• Establish and maintain personal relations to relevant persons in FDA and EU or other relevant authorities
• Participate in relevant conferences
• Monthly reporting
• Evaluation of necessarily of existing registrations
• Participate in yearly risk assessments
• Establish internal monograph for new business areas
  

 
Required Qualities, Skills and Experience / Competences:

• Life science education is preferable
• Strong knowledge in USP and EP requirements for solids, parental or ophthalmic products is preferable but medical devices is also acceptable
• Experience in DMF in US
• At least 3-5 years working with product registration and R&A
• EU Food approval is preferable
• Experience in product registration in other countries such as Russia, China is preferable
• Strong communication skills and customer friendly approach
• Fluent in English
• Pragmatic
• Negotiation skills

We offer:

• The possibility of development in international structures
• Attractive salary
• Good working conditions

Applications including CV and covering letter with reference number, please apply at the reception
Gerresheimer Bolesławiec S.A., ul. B. Chrobrego 15, 59-700 Bolesławiec
or via e-mail: d.stuczynska@gerresheimer.com
Please note that we do not pay the tenders submitted.

The deadline for applications expires on 06-02-2012

Prosimy o dopisanie następującej klauzuli „Wyrażam zgodę na przetwarzanie moich danych osobowych zawartych w ofercie dla potrzeb procesu rekrutacji zgodnie z Ustawą o ochronie danych osobowych z dnia 29.08.1997r., Dz. U. Nr 101, poz. 926 ze zm.” Numer w rejestrze agencji zatrudnienia: 361 hays.pl