Regulatory Associate - Publishing
Posted on :
19-06-2024
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Position Title: Regulatory Associate (publishing)
Reports To: Regulatory Affairs Manager
Position Summary: We are seeking a highly motivated and experienced Regulatory Associate to join our Regulatory Affairs team. The ideal candidate will have 24 years of publishing experience within the Biotech/Pharma/CRO industry. This role requires strong knowledge of Chemistry Manufacturing and Controls (CMC) Common Technical Document (CTD/eCTD/ACT) and regulatory requirements for the US EU and Rest of the World (ROW) countries.
Key Responsibilities:
- Prepare compile and submit regulatory documents in compliance with US EU and ROW regulatory requirements.
- Ensure accurate and timely publication of regulatory submissions including CMC sections in eCTD format.
- Maintain and manage regulatory submissions and related documents ensuring consistency and compliance with regulatory guidelines.
- Collaborate with crossfunctional teams including R&D Quality Assurance and Clinical Affairs to gather necessary documentation and information for regulatory submissions.
- Stay current with regulatory guidelines and industry best practices to ensure compliance with regulatory requirements.
- Assist in the preparation and maintenance of regulatory submission timelines and ensure adherence to project schedules.
- Review and provide feedback on regulatory documents to ensure accuracy and completeness.
- Support regulatory inspections and audits as needed.
- Participate in regulatory strategy development and provide input based on regulatory knowledge and experience.
Qualifications:
- Bachelors degree in Life Sciences Pharmacy or a related field. Advanced degree preferred.
- 24 years of regulatory publishing experience within the Biotech/Pharma/CRO industry.
- Strong knowledge of CMC CTD/eCTD/ACT formats and regulatory requirements for US EU and ROW countries.
- Proficient in regulatory submission software and electronic document management systems.
- Excellent organizational skills and attention to detail.
- Strong written and verbal communication skills.
- Ability to work effectively in a team environment and manage multiple projects simultaneously.
- Strong problemsolving skills and the ability to work under pressure to meet deadlines.
Preferred Qualifications:
- Experience with regulatory submissions in various phases of drug development (e.g. IND NDA BLA MAA).
- Knowledge of regulatory affairs processes and requirements for both drug and biologic products.
- Familiarity with regulatory agency interactions and meeting management.
project management,team collaboration,cmc,row,regulatory affairs,publishing
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
