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Head of Regulatory Affairs Slovakia
Pfizer
Place of work
Bratislava
Bratislava
Contract type
full-time
full-time
Wage (gross)
3 000 EUR/month3000.00 EUR/MONTH
3 000 EUR/month3000.00 EUR/MONTH
Information about the position
Job description, responsibilities and duties
Responsibilities:
• Lead and manage the country team in the development of regulatory strategies for registration of new products and line extensions, and their lifecycle management.
• Responsible for the leadership, development, and performance management of the country team
• Ensures that all regulatory activities in the country are managed in compliance with Pfizer standards and international/local regulations.
• Develop strong partnerships within the country and above-country functions and above-country WSR Therapeutic Area and Regional Teams.
• Provide strategic contribution to leadership team - anticipate what Regulatory needs to contribute to achieve business objectives.
• Collaborate with Consumer Health Regulatory country leads on regulatory positions for pan-portfolio or policy topics for communication to in-country internal and external stakeholders.
• Ensure internal regulatory processes and procedures are well documented and support compliant regulatory activities.
• Assure local licenses in country(ies) under responsibility are maintained in compliance with local regulations and following corporate policies, regulatory processes, SOPs
• Oversight of local Regulatory Authority approvals for Pfizer sponsored Clinical Trials and the maintenance of approved CTAs.
• Ensure Country Regulatory Strategy accountabilities as defined in Alliance Partner Task Ownership Matrix.
• Responsible for developing and enhancing relationships with key external entities.
• Partner with Regulatory Policy to develop and reinforce Pfizer regulatory positions with external stakeholders and understanding of the external environment.
• Understand local regulations and developing trends in the local regulatory environment of the countries under responsibility and provide assessment of the impact to key stakeholders.
• Active participation in the local Trade Association(s) and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business.
• Lead and manage the country team in the development of regulatory strategies for registration of new products and line extensions, and their lifecycle management.
• Responsible for the leadership, development, and performance management of the country team
• Ensures that all regulatory activities in the country are managed in compliance with Pfizer standards and international/local regulations.
• Develop strong partnerships within the country and above-country functions and above-country WSR Therapeutic Area and Regional Teams.
• Provide strategic contribution to leadership team - anticipate what Regulatory needs to contribute to achieve business objectives.
• Collaborate with Consumer Health Regulatory country leads on regulatory positions for pan-portfolio or policy topics for communication to in-country internal and external stakeholders.
• Ensure internal regulatory processes and procedures are well documented and support compliant regulatory activities.
• Assure local licenses in country(ies) under responsibility are maintained in compliance with local regulations and following corporate policies, regulatory processes, SOPs
• Oversight of local Regulatory Authority approvals for Pfizer sponsored Clinical Trials and the maintenance of approved CTAs.
• Ensure Country Regulatory Strategy accountabilities as defined in Alliance Partner Task Ownership Matrix.
• Responsible for developing and enhancing relationships with key external entities.
• Partner with Regulatory Policy to develop and reinforce Pfizer regulatory positions with external stakeholders and understanding of the external environment.
• Understand local regulations and developing trends in the local regulatory environment of the countries under responsibility and provide assessment of the impact to key stakeholders.
• Active participation in the local Trade Association(s) and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business.
Employee perks, benefits
In addition to competitive salaries and customized benefits packages, we offer a supportive and diverse culture.
3000 EUR upon candidate seniority
3000 EUR upon candidate seniority
Information about the selection process
Please apply in English documents only!
Requirements for the employee
Candidates with education suit the position
Secondary with school-leaving examination
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)
Personality requirements and skills
Qualifications:
• Scientific Degree - such as life sciences or chemistry. Pharmacist degree may be mandatory in some countries.
• A higher degree (MSc, MBA or PhD) may be an advantage but is not essential.
• Extensive experience in regulatory affairs, preferably in human medicines. Proven ability to manage complex regulatory issues.
• Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.
• Proven ability to consistently deliver to time, cost and quality standards.
• General management experience and previous line management and leadership experience at senior management level is essential
• Demonstrable experience of effective delivery in a complex matrix environment.
• Strong leadership qualities and management skills, including talent development, team working, problem solving, communication and interpersonal skills.
• In depth knowledge of national/regional regulatory legislation and guidelines. Understanding of business and financial environment, drug development process and the pharmaceutical industry.
• Knowledge and understanding of quality systems, processes, audit and inspections.
• Ability to influence at all levels in the organization and build networks internal and externally.
• Scientific Degree - such as life sciences or chemistry. Pharmacist degree may be mandatory in some countries.
• A higher degree (MSc, MBA or PhD) may be an advantage but is not essential.
• Extensive experience in regulatory affairs, preferably in human medicines. Proven ability to manage complex regulatory issues.
• Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.
• Proven ability to consistently deliver to time, cost and quality standards.
• General management experience and previous line management and leadership experience at senior management level is essential
• Demonstrable experience of effective delivery in a complex matrix environment.
• Strong leadership qualities and management skills, including talent development, team working, problem solving, communication and interpersonal skills.
• In depth knowledge of national/regional regulatory legislation and guidelines. Understanding of business and financial environment, drug development process and the pharmaceutical industry.
• Knowledge and understanding of quality systems, processes, audit and inspections.
• Ability to influence at all levels in the organization and build networks internal and externally.
Advertiser
Brief description of the company
Breakthroughs That Change Patients' Lives: Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.To learn more, visit www.pfizer.com.
ID: 3703723
Dátum zverejnenia: 26.6.2019
2019-06-26
lokalita: Bratislava Pozícia: Regulatory Affairs Manager, Regulatory Affairs Specialist Spoločnosť: Pfizer
Základná zložka mzdy (brutto) a ďalšie odmeny: 3 000 EUR/month3000.00 EUR/MONTH