Job Information
Parexel Senior Regulatory Affairs Associate (Marketing Application) in Argentina
The Senior Associate will p rovide an overview of the responsibilities of the position by providing a summary of the most important aspects and duties of the position.
Lead Local Regulatory Responsible (LRR) oversees LRRs to ensure effective deicion making and mooth operations and acts as the first escalation point for LRR challenges.
Local Regulatory Responsible focuses on local regulatory requirements and Health Authority national engagements.
The key interactions are with local external stakeholders e.g. Health Authorities, Local industry association(s), In Market commercial counterpart and Regional Regulatory Lead (RRL) counterparts in respective GRA Regional team
Experience:
5+ years of (local) regulatory knowledge and experience in a regulatory authority facing role; i.e. comprehensive understanding of regional and global regulatory requirements, guidelines and processes
Leadership experience
In-depth expertise on local health authority management
Project management skills and leadership skills; i.e. proven experience in managing e.g., regulatory submissions, timelines and cross-functional teams to ensure timely and successful product registrations and compliance
Experience in managing ComOps Stakeholders: matching influencing style to stakeholders to maximise impact and effectiveness of GRA expertise, proactively identifying opportunities to influence stakeholders on business critical decisions and employing a systematic approach to influence key internal stakeholders based on business needs and objectives
Experience in successfully dealing with rapid change
Competence:
Fluent in local language and English, oral and written
Relevant bachelor’s degree or equivalent secondary education e.g. natural sciences (biology, chemistry with pharmacological focus)
Expert MS Office skills
Excellent organizational, time management and interpersonal skills in a global environment.
Ability to work successfully in a complex global matrix organization.
Proven ability to work effectively both independently and in a team.
The expertise, determination and courage to resolve or escalate issues as appropriate.
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.