Regulatory Affairs Analyst

2 semanas atrás

Sao Paulo, Brasil MSD Tempo inteiro

**Job Description**:**SUMMARY**The Associate Specialist, Regulatory Affairs supports a variety of regulatory and cross-functional initiatives and executes/ tracks all activities associated to different types of regulatory submissions and products, in collaboration with internal and external stakeholders, following global and local strategies and oriented by the Company values: patients first, ethics and integrity, respect for people and innovation and scientific excellence.**RESPONSIBILITIES**- Contact with internal and external stakeholders, including local and regional organizations, external partners and trade association;- Support regulatory and competitive intelligence initiatives, including impact assessment of new regulations and competitors monitoring;- Support exportation projects / CPP requests if needed;- Support ANVISA GMPc requests on projects demand;- Support artwork development for packaging components (regulatory text elaboration and revision; artwork revision and approval);- Elaboration, review and implementation of Standards Operational Procedures (SOP) and associated procedural documents;- Ensure data integrity and accuracy through local and global regulatory systems and trackers;- Support the interns and other colleagues with their specific activities on demand/ if needed.**QUALIFICATIONS, SKILLS & EXPERIENCE**- Academic background: Complete higher education in Pharmacy;- Knowledge and Experience: experience in the Regulatory Affairs field. Regulatory knowledge of biological products is desirable;- Languages: English business proficient (mandatory); Spanish elementary knowledge is desirable;- Technological skills: MS Office (Word, Excel, Power Point); ability to work with multiple systems;- Important soft skills: written and oral communication; sense of collaboration; effective organization and analytical thinking.**We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.****Search Firm Representatives Please Read Carefully****Employee Status**:Regular**Relocation**:**VISA Sponsorship**:**Travel Requirements**:**Flexible Work Arrangements**:**Shift**:**Valid Driving License**:**Hazardous Material(s)**:**Requisition ID**:R

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