Senior Regulatory Affairs Associate (Marketing Application)

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The Senior Associate will provide 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.

Originally posted on Himalayas