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20.11.2020

Regulatory Affairs Director - China

  • China - Beijing
  • Vollzeitstelle

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Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist.
Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen.
Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.
Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.
Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist.
Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen.
Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.
Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Regulatory Affairs Director - China

Location: China - Beijing
Function: Regulatory Affairs
Company: Vifor Pharma
Medha Khanna
Senior Talent Acquisition Manager

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Agency policy
About you

Are you an experienced regulatory affairs professional with strategic experience of new product registration in China?

Vifor Pharma has a newly created opportunity for a Regulatory Affairs Director based in Beijing, China to lead the regulatory function in the local affiliate and drive strategies to accelerate regulatory approval for our product portfolio in China.

Key responsibilities

  • Manage, guide and develop the local RA team, ensure planned local regulatory affairs activities are delivered in time and proper local Regulatory procedures and policies are in place.

  • Support Global Regulatory Affairs in accelerating the approval of Vifor portfolio in as a key RA SME for specific considerations related to regulatory frameworks in China.

  • Act as RA lead to develop advocacy, support Authority management with stakeholder mapping and proactively build and strengthen external stakeholder contacts (external experts, industry organizations, etc) in China

  • Develop and evaluate registrations as well as clinical strategies to ensure effective achievement of regulatory/business objectives, approvals, and optimal labels.

  • Act as key regulatory affairs subject matter expert for specific considerations related to relevant strategic objectives regarding Advocacy, functional capabilities, and clinical design strategies.

  • Proactively address industry trends and opportunities, and key regulatory trends related to registration requirements, clinical development and clinical requirements supporting new product approval.

  • Act as primary Vifor RA representative in front of the CDE in collaboration with Global RA International Strategy group.

  • Provide input for GRA International Strategy in interpreting public information related to approval of products and on conditions for building regulatory dossiers to support the safety, efficacy, medical usefulness, and marketability of drug and product candidates in China.

  • Review and ensure that the design and conduct of clinical development programs and individual studies are appropriate to generate data supportive of registration in China.

Requirements

  • Advanced degree in pharmaceutical or health related field

  • At least 10-12 years’ experience with regulatory affairs in the pharmaceutical industry (prescription drugs) in China

  • Demonstrated experience managing regulatory strategy and submission of dossiers including study design, data review, approval strategies and labelling negotiations in China

  • Demonstrated experience interacting with local health authority bodies and local health experts

  • Solid knowledge of the Chinese regulatory environment, clinical practice regulations in China

  • Proficiency in Mandarin and English (verbal and written) is essential

  • Experience in pharmacovigilance regulations is a plus

  • Experience in anaemia, nephrology, rare diseases or speciality drug development is preferred

 
About us

Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives.

Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world.

The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.

Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.

For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are

Apply
Agency policy

Regulatory Affairs Director - China

Are you an experienced regulatory affairs professional with strategic experience of new product registration in China?

Vifor Pharma has a newly created opportunity for a Regulatory Affairs Director based in Beijing, China to lead the regulatory function in the local affiliate and drive strategies to accelerate regulatory approval for our product portfolio in China.

Key responsibilities

  • Manage, guide and develop the local RA team, ensure planned local regulatory affairs activities are delivered in time and proper local Regulatory procedures and policies are in place.

  • Support Global Regulatory Affairs in accelerating the approval of Vifor portfolio in as a key RA SME for specific considerations related to regulatory frameworks in China.

  • Act as RA lead to develop advocacy, support Authority management with stakeholder mapping and proactively build and strengthen external stakeholder contacts (external experts, industry organizations, etc) in China

  • Develop and evaluate registrations as well as clinical strategies to ensure effective achievement of regulatory/business objectives, approvals, and optimal labels.

  • Act as key regulatory affairs subject matter expert for specific considerations related to relevant strategic objectives regarding Advocacy, functional capabilities, and clinical design strategies.

  • Proactively address industry trends and opportunities, and key regulatory trends related to registration requirements, clinical development and clinical requirements supporting new product approval.

  • Act as primary Vifor RA representative in front of the CDE in collaboration with Global RA International Strategy group.

  • Provide input for GRA International Strategy in interpreting public information related to approval of products and on conditions for building regulatory dossiers to support the safety, efficacy, medical usefulness, and marketability of drug and product candidates in China.

  • Review and ensure that the design and conduct of clinical development programs and individual studies are appropriate to generate data supportive of registration in China.

Requirements

  • Advanced degree in pharmaceutical or health related field

  • At least 10-12 years’ experience with regulatory affairs in the pharmaceutical industry (prescription drugs) in China

  • Demonstrated experience managing regulatory strategy and submission of dossiers including study design, data review, approval strategies and labelling negotiations in China

  • Demonstrated experience interacting with local health authority bodies and local health experts

  • Solid knowledge of the Chinese regulatory environment, clinical practice regulations in China

  • Proficiency in Mandarin and English (verbal and written) is essential

  • Experience in pharmacovigilance regulations is a plus

  • Experience in anaemia, nephrology, rare diseases or speciality drug development is preferred

Vifor Pharma
Regulatory Affairs

Arbeitsort:

China - Beijing

Medha Khanna
Senior Talent Acquisition Manager