Analista Compliance – Sênior
Transfeera
Senior Scientist, Regulatory Affairs – Chemistry Manufacturing & Controls (CMC)
Simplify
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇧🇷 Brazil
Visit company websiteJob Level
Senior
About the role
- Responsible for assessment of changes for regulatory impact.
- Development of regional CMC strategy.
- Preparation of CMC documentation and execution of regional post-approval CMC supplements and new product registrations.
- Ensure right first-time submissions to Health Authorities.
- Work closely with CMC Product Leads to ensure that Organon’s key CMC projects are successfully prosecuted in the region.
- Implementing regional CMC strategy for international markets.
- Support Organon Country RA affiliate interactions with their local Regulatory Agencies.
- Act as Regulatory CMC SME in regional post approval requirements.
- Ensure high quality and timely responses to Regulatory Agency questions.
- Drive continuous process improvement activities within the organization.
Requirements
- The candidate must possess a Bachelor’s or Master’s Degree in chemistry, pharmacy, biology or a related science.
- Minimum of 4 years of experience in the pharmaceutical industry, in Regulatory Affairs and/or Technical Regulatory.
- The ideal candidate will have experience in Regulatory Affairs for the regional markets.
- Focus on Regulatory CMC requirements for small molecule/biologic/biosimilar products, development, manufacturing and/or quality assurance.
- Direct Health Authority experience would be an advantage.
- Demonstrate effective problem solving and understanding of regulatory strategies.
- Excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks.
- Must have a proven ability to communicate effectively in both a written and verbal format.
- Fluent in 1-2 languages spoken in the region of responsibility, in addition to English.
Benefits
- Appointment to this position will be on local salary and benefits package.
- As an equal opportunity employer, we welcome applications from candidates with a diverse background.
- We are committed to creating an inclusive environment for all our applicants.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Regulatory AffairsCMC documentationRegulatory CMC requirementssmall molecule productsbiologic productsbiosimilar productsdevelopmentmanufacturingquality assuranceregulatory strategies
Soft skills
problem solvinginterpersonal skillsdetail orientedprioritizationcommunication skills
Certifications
Bachelor’s DegreeMaster’s Degree
