Regulatory Affairs Analyst
Há 1 mês
**About Us**
Bristol-Myers Squibb is a global biopharmaceutical company that is transforming patients' lives through innovative medicines and vaccines. We are committed to delivering innovative medicines that help patients overcome some of the most challenging diseases of our time.
**Job Summary**
We are seeking a highly motivated and experienced Regulatory Affairs Analyst to join our team in Brazil. The successful candidate will be responsible for ensuring that our products are compliant with all relevant regulatory requirements and will play a key role in the development and implementation of our regulatory strategies.
**Key Responsibilities**
Understands and fulfills current and local regulations and internal policies while assessing, planning and executing regulatory processes.
Planning, preparing, submitting and tracking thru approval non-asset specific regulatory processes required for the continuity of BMS operations in Brazil.
Preparing registration renewal, HMP and regulatory low-mid complexity filings without major supervision.
Assisting on preparation of major filings under certain supervision, like BLA, NDA, LCM and DDCM, according to pipeline submission plans tightly aligned with the endorsed strategy and targeted timelines.
Preparing comprehensive and timely responses to HA queries.
Providing ToC (table of contents) related to registration and PAV (post approval variations) to Global GRS teams.
Preparing and submitting extemporaneous mandatory notifications (i.e. OOS, shortages, quality deviations, recalls, etc.) and following up on derived actions until completion.
Feeding in a timely basis BMS databases to maintain regulatory records fully accurate and updated.
**Requirements**
Bachelor's degree in a relevant field (e.g. Life Sciences, Pharmacy, Chemistry).
Minimum 2 years of experience in Regulatory Affairs, preferably in the pharmaceutical industry.
Strong knowledge of regulatory requirements and procedures in Brazil.
Excellent communication and interpersonal skills.
Ability to work in a team environment and prioritize multiple tasks and deadlines.
**What We Offer**
Competitive salary and benefits package.
Opportunities for professional growth and development.
Collaborative and dynamic work environment.
Recognition and rewards for outstanding performance.
**How to Apply**
If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, please submit your application, including your resume and cover letter, to our website.
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