Regulatory Affairs Consultant
Found in: beBee S IN - 2 weeks ago
Regulatory Affairs Consultant.
8+ years’ experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantageExperience in handling CMC related health authority queriesGood understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.Liaise closely with cross-functional members with aligned product responsibilities.Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.To prepare, review and submit safety variations to Health Authorities and also perform post Approval CMC related updates (where applicable).Prior working experience in Regulatory Information Management Systems like Veeva Vault would be desirable.Strong communications skillsAbility to work independently.-
Regulatory Affairs Consultant
Found in: beBee jobs IN - 1 week ago
Hyderabad, Telangana, India Parexel Full timeRegulatory Affairs Consultant.8+ years' experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute...
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Regulatory Affairs Consultant
Found in: Whatjobs IN C2 - 1 week ago
hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Regulatory Affairs Consultant. 8+ years’ experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market. Good understanding of regulatory framework, including regional...
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Regulatory Affairs Consultant
Found in: Talent IN C2 - 2 weeks ago
Hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Regulatory Affairs Consultant. 8+ years’ experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market. Good understanding of regulatory framework, including regional...
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Regulatory Affairs Consultant
Found in: Whatjobs IN C2 - 1 week ago
hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Regulatory Affairs Consultant. 8 years’ experience in handling life cycle management of approved drug products (small molecules) in various markets. Good understanding of regulatory framework, including regional trends, for various types of applications and procedures Lead and...
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Regulatory Affairs Consultant
Found in: Talent IN C2 - 2 weeks ago
Hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Regulatory Affairs Consultant. 8 years’ experience in handling life cycle management of approved drug products (small molecules) in various markets. Good understanding of regulatory framework, including regional trends, for various types of applications and procedures Lead and /...
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Regulatory Affairs Associate
Found in: beBee S IN - 2 weeks ago
Hyderabad, India Parexel Full timeRegulatory Affairs Associate2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.• To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.• To provide regulatory input on procedural and CMC documentation...
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Regulatory Affairs Associate
Found in: beBee jobs IN - 1 week ago
Hyderabad, Telangana, India Parexel Full timeRegulatory Affairs Associate2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.To provide regulatory input on procedural and CMC documentation...
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Regulatory Affairs Associate
Found in: Whatjobs IN C2 - 1 week ago
hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Regulatory Affairs Associate 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.• To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all...
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Regulatory Affairs Associate
Found in: Talent IN C2 - 2 weeks ago
Hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Regulatory Affairs Associate 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. • To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all...
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Sr. Regulatory Affairs
Found in: Whatjobs IN C2 - 1 week ago
hyderabad, India Kamet Consulting Group Full timeJob Description:It's an exciting time to join Kamet Consulting Group as we continue our hyper growth journey. We encourage entrepreneurial culture, spirit, which empowers individuals to think creatively, take initiatives, and drive innovative solutions.We are looking for a Sr. Regulatory Affairs / Regulatory Intelligence Associate (Pharmaceutical and...
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Sr. Regulatory Affairs
Found in: Whatjobs IN C2 - 7 days ago
Hyderabad, India Kamet Consulting Group Full timeJob Description: It's an exciting time to join Kamet Consulting Group as we continue our hyper growth journey. We encourage entrepreneurial culture, spirit, which empowers individuals to think creatively, take initiatives, and drive innovative solutions. We are looking for a Sr. Regulatory Affairs / Regulatory Intelligence Associate (Pharmaceutical and...
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Regulatory Affairs, Associate
4 days ago
Hyderabad, India Cellix Bio Full timeHere, everyone matters and you will be a vital contributor to our inspiring, bold mission. You will help make an impact on people’s lives and change futures every day. We are equally committed to bringing out your best and fostering a collaborative workplace built on trust and respect. We empower our people to take charge of their potential. We offer...
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Sr. Regulatory Affairs
Found in: Whatjobs IN C2 - 1 week ago
Hyderabad, India Kamet Consulting Group Full timeJob Description: It's an exciting time to join Kamet Consulting Group as we continue our hyper growth journey. We encourage entrepreneurial culture, spirit, which empowers individuals to think creatively, take initiatives, and drive innovative solutions. We are looking for a Sr. Regulatory Affairs / Regulatory Intelligence Associate (Pharmaceutical and...
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Sr. Regulatory Affairs
Found in: Talent IN 2A C2 - 1 week ago
Hyderabad, India Kamet Consulting Group Full timeJob Description:It's an exciting time to join Kamet Consulting Group as we continue our hyper growth journey. We encourage entrepreneurial culture, spirit, which empowers individuals to think creatively, take initiatives, and drive innovative solutions.We are looking for a Sr. Regulatory Affairs / Regulatory Intelligence Associate (Pharmaceutical and Medical...
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Sr. Regulatory Affairs
Found in: Appcast Linkedin IN C2 - 1 week ago
Hyderabad, India Kamet Consulting Group Full timeJob Description:It's an exciting time to join Kamet Consulting Group as we continue our hyper growth journey. We encourage entrepreneurial culture, spirit, which empowers individuals to think creatively, take initiatives, and drive innovative solutions.We are looking for a Sr. Regulatory Affairs / Regulatory Intelligence Associate (Pharmaceutical and Medical...
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Senior Regulatory Affairs Associate
Found in: beBee S IN - 3 weeks ago
Hyderabad, India Parexel Full timeRegulatory Affairs LabelingBachelor’s Degree plus at least 5 to 8 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI,...
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Senior Regulatory Affairs Associate
Found in: beBee S IN - 2 weeks ago
Hyderabad, India Parexel Full timeRegulatory Affairs LabelingBachelor’s Degree plus at least 5 to 8 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI,...
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Senior Regulatory Affairs Associate
Found in: beBee jobs IN - 1 week ago
Hyderabad, Telangana, India Parexel Full timeRegulatory Affairs LabelingBachelor's Degree plus at least 5 to 8 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging)The...
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Senior Regulatory Affairs Associate
Found in: Talent IN C2 - 2 weeks ago
Hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Regulatory Affairs Labeling Bachelor’s Degree plus at least 5 to 8 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. Good working knowledge of key labeling...
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Senior Regulatory Affairs Associate
Found in: Whatjobs IN C2 - 1 week ago
hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Regulatory Affairs Labeling Bachelor’s Degree plus at least 5 to 8 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. Good working knowledge of key labeling...