Senior Regulatory Affairs Associate

Há 7 dias

Brasília DF, Brasil Parexel Tempo inteiro

Key Responsibilities:

- Demonstrate a thorough understanding of the structure and authoring requirements for US Prescribing Information (USPI) and Canada Product Monographs.
- Utilize advanced Microsoft Word editing skills, specifically for structured labeling documents.
- Interact directly with clients, addressing their needs and queries related to labeling processes and requirements.
- Ensure all labeling documents comply with regulatory standards and guidelines.
- Collaborate with cross-functional teams to coordinate labeling activities and timelines.
- Stay updated on regulatory changes and industry best practices in labeling.

Qualifications:

- Bachelor's degree in Life Sciences, Pharmacy, or a related field (advanced degree preferred).
- Minimum of 3-5 years of experience in regulatory affairs or labeling within the pharmaceutical industry.
- In-depth knowledge of global regulatory labeling requirements, with a focus on EU, US, and Canadian markets.
- Proficiency in advanced Microsoft Word features, particularly those related to structured labeling.
- Excellent written and verbal communication skills in English.
- Strong attention to detail and ability to manage multiple projects simultaneously.
- Proven experience in client-facing roles within the pharmaceutical or healthcare industry.

**Required Skills**:

- Expertise in regulatory labeling processes and timelines.
- Proficiency in authoring and editing USPI and Canada Product Monographs. Advanced Microsoft Word skills, particularly in structured labeling techniques. Strong interpersonal and communication skills for effective client interactions. Ability to work independently and as part of a team in a fast-paced environment.

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