CMC Regulatory Affairs Specialist

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...

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...

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...

About the RoleThis is an exciting opportunity for a motivated and experienced Regulatory Affairs Chemistry Specialist to join our team at Novo Nordisk A/S. As a CMC Regulatory Specialist, you will provide expert advice on regulatory requirements for clinical trial applications (CTAs) and marketing authorizations (MAAs).You will be responsible for ensuring...

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...

Select how often (in days) to receive an alert: Create AlertExpert in Regulatory Affairs - Primary PackagingCategory: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKAre you ready to take on new challenges in primary packaging development across emerging therapeutic areas and innovative products? Would you like to use...

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...

Key ResponsibilitiesApplying regulatory intelligence and establishing strategy for submission of clinical trial applications (CTAs) and marketing authorisations (MAAs)Submission of regulatory files and responding to questions from health authoritiesEnsuring the preparation, review and submission of pre-meeting packages for health authority meetings as well...

Select how often (in days) to receive an alert: Create Alert Regulatory Affairs Business Development Director Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK Do you have experience developing medicinal products and identifying regulatory risks and opportunities? Are you knowledgeable about the drug...

Select how often (in days) to receive an alert: Create AlertRegulatory Affairs Business Development DirectorCategory: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKDo you have experience developing medicinal products and identifying regulatory risks and opportunities? Are you knowledgeable about the drug development...

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...

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...

At Novo Nordisk, we are committed to creating innovative solutions to improve the lives of patients worldwide.Company OverviewWe strive to be a leader in our industry by pushing boundaries, embracing new technologies, and fostering a culture of collaboration and innovation.The Regulatory Affairs Business Development team is responsible for evaluating...

About the CompanyWe are Reckitt Benckiser, a global leader in hygiene, health, and nutrition. Our purpose is to protect, heal, and nurture in the pursuit of a cleaner, healthier world.The RoleAs a Regulatory Affairs Associate within our Hygiene division, you will be at the forefront of innovation and compliance efforts. You will work closely with a dynamic...

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...

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 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...

About the DepartmentDigital Transformation is a department placed in RQ&C: RQ&C consists of the four functional areas: Regulatory Affairs (approvals by health authorities), R&D Quality (ensuring quality and compliance), Clinical Reporting (medical writing) and Digital Transformation (driving the Digital agenda). Furthermore, our department also supports the...

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...