Regulatory Affairs Specialist

Position Summary The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations...

Regulatory Affairs Publishing AssociateThis role is ideal for a highly skilled and experienced Regulatory Affairs professional who has expertise in regulatory publishing, document management, and stakeholder engagement. As a Regulatory Affairs Publishing Associate, you will play a key role in supporting global regulatory submission activities by managing...

About Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...

About Halma:Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...

We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates,...

We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates,...

About the CompanyRedica Systems is a data analytics start-up serving over 200 customers in the life sciences sector, with a particular focus on Pharmaceuticals and MedTech. Our team is distributed globally, with headquarters in Pleasanton, CA. Redica’s platform empowers companies to enhance product quality and stay ahead of evolving regulations. Using...

Establish a leadership position in oncology medical affairs by driving scientific and technical initiatives that advance the company's objectives.Key Responsibilities:Represent the company as a subject matter expert in oncology, fostering credible relationships with external experts and healthcare professionals.Develop and execute strategic plans for...

Key Responsibilities:Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing.Compile, format, and publish regulatory documents according to global health authority requirements.Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.Perform QC of eCTD submissions, including...

Compliance Excellence SpecialistWe are seeking a highly skilled Compliance Excellence Specialist to join our team. This is an exciting opportunity to contribute to the success of our organization by ensuring the highest standards of compliance and quality assurance.Key Responsibilities:Conduct thorough assessments of alerts, escalations, and investigations...