Synthetic Small Molecules Regulatory Lead

The Ideal CandidateWe are looking for an experienced Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic small molecules to join our team. The ideal candidate will have a Master's and/or Ph.D. degree in life sciences with regulatory CMC experience either from the pharmaceutical industry or from a health...

Job DescriptionThis role offers a unique opportunity to join a dynamic team in a fast-paced, global environment. As a CMC Regulatory Specialist, you will play a critical role in ensuring the successful development and approval of our synthetic small molecule projects. Your expertise in regulatory affairs, combined with your knowledge of synthetic small...

About the RoleWe are seeking an experienced Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist to join our Synthetics & Cell Technologies Department in the RA CMC Biotech & Rare Disease area within Novo Nordisk.The successful candidate will provide strategic, tactical, and operational regulatory input to projects, leading activities...

QualificationsA Master and/or Ph.D. degree in life sciences with regulatory CMC experience either from the pharmaceutical industry or from a health authority.A minimum of 8+ years of experience with synthetic small molecules experience is preferred, as well as experience in the following areas:In-depth knowledge of regulatory CMC requirements for clinical...

About the RoleWe are seeking an experienced Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic small molecules to join our team. As a key member of our regulatory affairs department, you will provide strategic, tactical, and operational regulatory input to projects. Your responsibilities will include...

Job OverviewWe are seeking an experienced CMC Regulatory Specialist to join our team in Novo Nordisk A/S. As a key member of our regulatory affairs department, you will be responsible for providing strategic, tactical, and operational regulatory input to projects.The ideal candidate will have expertise in synthetic small molecules and experience working with...

Select how often (in days) to receive an alert: Create AlertCategory: Reg Affairs & Safety PharmacovigilanceLocation: Søborg, Capital Region of Denmark, DKWe are expanding our product and project pipeline in Novo Nordisk and are looking for an engaged Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic...

Select how often (in days) to receive an alert: Create Alert Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK We are expanding our product and project pipeline in Novo Nordisk and are looking for an engaged Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic...

ResponsibilitiesAs a CMC Regulatory Expertise Opportunity, you will be responsible for:Applying regulatory intelligence and establishing strategy for submission of clinical trial applications (CTAs) and marketing authorizations (MAAs)Submission of regulatory files and responding to questions from health authoritiesEnsuring the preparation, review, and...

About the Role:We are seeking a highly skilled Regulatory Affairs Business Development Director to join our team at Novo Nordisk A/S. As a member of our Regulatory Affairs Diabetes and Obesity team, you will play a pivotal role in creating global regulatory strategies to advance projects from the early stages of development to worldwide submissions and...

Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK Are you able to cut through complexity and drive regulatory strategies for high impact projects? Would you like to work together with experts across multiple functions in a global environment? Do you want to be part of an exciting area where engaged people are...

Key ResponsibilitiesAs a Regulatory Affairs Business Development Director at Novo Nordisk, you will be responsible for:Leading RA BD activities and establishing a Matrix Team covering all relevant regulatory skill areas.Evaluating external assets and companies for in-licensing, partnerships, or acquisitions across Novo Nordisk's therapeutic...

About Novo Nordisk A/SWe are a dynamic company in an even more dynamic industry, always striving to drive change and move the needle on patient care.Our team is responsible for developing and executing global regulatory strategies, advancing projects across multiple indications from early development through worldwide submission and approval.As a Global...

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About This RoleWe are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team within RA Obesity.In this role, you will be responsible for developing and executing late-stage regulatory strategies, collaborating with cross-functional teams, and overseeing regulatory submissions.Key responsibilities may include:Providing...

Company Overview:Novo Nordisk A/S is a leading healthcare company that focuses on developing innovative treatments for people with diabetes and other serious chronic conditions. Our vision is to make a significant difference in patients' lives by delivering high-quality products and services.We are committed to fostering a culture of innovation,...

Job Description:We are seeking a highly skilled Regulatory Affairs Business Development Director to join our team at Novo Nordisk A/S.The successful candidate will have a strong background in regulatory affairs and business development, with experience in evaluating external assets and companies for in-licensing, partnerships, or acquisitions. They will also...

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Job Description:We are seeking a highly skilled Regulatory Affairs Specialist to join our team in the Cardiovascular & Chronic Kidney Diseases (CVD/CKD) therapeutic area. As a Global Regulatory Lead, you will be responsible for developing regulatory strategies and executing various regulatory tasks within cross-functional project teams.Your key...

Select how often (in days) to receive an alert: Create Alert Regulatory Affairs Specialist, RA Obesity Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK Are you passionate about regulatory science and driving innovative regulatory strategies to bring innovative medicines to patients? Do you have strong...