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Global Regulatory Affairs and Pharmacovigilance Manager, Therapeutic Enzymes

Global Regulatory Affairs and Pharmacovigilance Manager, Therapeutic Enzymes

Epalinges, CH

Epalinges, CH

 

NHSc is headquartered in Switzerland and employs over 5,000 people around the world. We currently produce over a billion nutritional health solutions for consumers, patients and their healthcare providers. We also distribute industry-leading Vitamins, Minerals and Supplements brands (VMS) in both the healthcare practitioner and consumer channels, making NHSc uniquely positioned to cater to the most pressing health concerns of today.

 

Position Snapshot

 

Location:Epalinges, Switzerland
Company: Nestlé Health Science
Permanent Contract
Full-time, Act. Rate 100%
5+ years of experience in global drug regulatory affairs including US and EU

 

Position Summary

 

As a Global Regulatory Affairs and Pharmacovigilance Manager, Therapeutic Enzymes you will manage Regulatory Affairs and Pharmacovigilance for the NHSc Therapeutic Enzymes drug category including maintenance of existing products and development of new products. 

A day in the life of a Global Regulatory Affairs and Pharmacovigilance Manager, Therapeutic Enzymes

 

  • Manage and coordinate regulatory activities (RA) worldwide to maintain existing enzyme drug licenses including maintenance of a validated regulatory database, regulatory dossier and label updates, variations, and new applications for new indications
  • Manage regulatory activities worldwide to develop new enzyme drug therapies in-house and in cooperation with third parties including preparation of IND/CTA dossiers, NDA/MAA dossiers, coordination of health authority interactions (e.g., scientific advice meetings) 
  • Define global regulatory strategy for new enzyme drug developments in close cooperation with Global Head of Regulatory Affairs and Head of Science and Medical Organization
  • Manage and coordinate interactions with NHSc RA representives (internal and/or third party) in regions and countries
  • Manage and coordinate pharmacovigilance (PV) process and system for enzyme drug therapies worldwide, both for existing drug products and new developments in the enzyme drug therapy category
  • Ascertain a PV system which is ready to pass PV audits by health authorities
  • Oversee and coordinate adverse event (AE) reporting process including an internal escalation process for serious unexpected AEs and quality issues associated with AEs
  • Oversee and coordinate PV activities in countries worldwide in close cooperation with country PV responsible (internal and/or external)
What will make you successful

 

  • Medical or biomedical university degree
  • At least 5 years of experience in global drug regulatory affairs including US and EU
  • Experience with biological drugs is preferred
  • At least 5 years of experience in global PV management including US and EU
  • Experience of working in an international environment with ability to co-ordinate activities across regions/countries
  • Experience dealing with country health authorities

 

The Nestlé Group is the world’s largest food and beverage company with 92.6 billion Swiss Francs in sales in 2019. It is present in 190 countries around the world, has 413 factories and its 308,000 employees are committed to Nestlé’s purpose of enhancing quality of life and contributing to a healthier future. Nestlé offers a wide portfolio of products and services for people and their pets throughout their lives. Its more than 2000 brands range from global icons like Nescafé or Nespresso to local favorites. Company performance is driven by its Nutrition, Health and Wellness strategy. Nestlé is based in the Swiss town of Vevey where it was founded more than 150 years ago. Learn more about our Group and reasons to join us on www.nestle.com. 

 

NHSc is headquartered in Switzerland and employs over 5,000 people around the world. We currently produce over a billion nutritional health solutions for consumers, patients and their healthcare providers. We also distribute industry-leading Vitamins, Minerals and Supplements brands (VMS) in both the healthcare practitioner and consumer channels, making NHSc uniquely positioned to cater to the most pressing health concerns of today.

 

Position Snapshot

 

Location:Epalinges, Switzerland
Company: Nestlé Health Science
Permanent Contract
Full-time, Act. Rate 100%
5+ years of experience in global drug regulatory affairs including US and EU

 

Position Summary

 

As a Global Regulatory Affairs and Pharmacovigilance Manager, Therapeutic Enzymes you will manage Regulatory Affairs and Pharmacovigilance for the NHSc Therapeutic Enzymes drug category including maintenance of existing products and development of new products. 

A day in the life of a Global Regulatory Affairs and Pharmacovigilance Manager, Therapeutic Enzymes

 

  • Manage and coordinate regulatory activities (RA) worldwide to maintain existing enzyme drug licenses including maintenance of a validated regulatory database, regulatory dossier and label updates, variations, and new applications for new indications
  • Manage regulatory activities worldwide to develop new enzyme drug therapies in-house and in cooperation with third parties including preparation of IND/CTA dossiers, NDA/MAA dossiers, coordination of health authority interactions (e.g., scientific advice meetings) 
  • Define global regulatory strategy for new enzyme drug developments in close cooperation with Global Head of Regulatory Affairs and Head of Science and Medical Organization
  • Manage and coordinate interactions with NHSc RA representives (internal and/or third party) in regions and countries
  • Manage and coordinate pharmacovigilance (PV) process and system for enzyme drug therapies worldwide, both for existing drug products and new developments in the enzyme drug therapy category
  • Ascertain a PV system which is ready to pass PV audits by health authorities
  • Oversee and coordinate adverse event (AE) reporting process including an internal escalation process for serious unexpected AEs and quality issues associated with AEs
  • Oversee and coordinate PV activities in countries worldwide in close cooperation with country PV responsible (internal and/or external)
What will make you successful

 

  • Medical or biomedical university degree
  • At least 5 years of experience in global drug regulatory affairs including US and EU
  • Experience with biological drugs is preferred
  • At least 5 years of experience in global PV management including US and EU
  • Experience of working in an international environment with ability to co-ordinate activities across regions/countries
  • Experience dealing with country health authorities

 

The Nestlé Group is the world’s largest food and beverage company with 92.6 billion Swiss Francs in sales in 2019. It is present in 190 countries around the world, has 413 factories and its 308,000 employees are committed to Nestlé’s purpose of enhancing quality of life and contributing to a healthier future. Nestlé offers a wide portfolio of products and services for people and their pets throughout their lives. Its more than 2000 brands range from global icons like Nescafé or Nespresso to local favorites. Company performance is driven by its Nutrition, Health and Wellness strategy. Nestlé is based in the Swiss town of Vevey where it was founded more than 150 years ago. Learn more about our Group and reasons to join us on www.nestle.com. 

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