As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Level: Mid
- Travel: Yes
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Success Profile
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Management
Strong management with depth of experience working for global health authorities.
Responsibilities
Parexel are seeking a highly skilled International Markets Regulatory Affairs Expert to join our dynamic team! We are looking for an experienced Regulatory Affairs professional with a broad understanding of regulatory science and requirements across international regions, particularly in emerging markets. The successful candidate will provide strategic guidance on regulatory submissions and lifecycle maintenance across international regions. If you are passionate about regulatory affairs and want to make a significant impact in the pharmaceutical industry, we encourage you to apply.
This role can be home or office based is selected European locations.
Key Responsibilities:
Develop International Regulatory Submission Strategies for a wide variety of products/projects
Support Project Leads in optimizing strategies for specific submissions in local markets
Guide delivery teams in creating International dossiers
Identify and mitigate risks related to international submissions
Conduct regulatory intelligence surveys and provide objective assessments
Represent the company at health authority meetings and document discussions and agreements
Coach, mentor, and lead regulatory teams to ensure timely and quality delivery of objectives
Monitor and advise on key changes in the regulatory environment of International markets
Qualifications:
University Degree in a Scientific or Technical Discipline
Several years of experience in pharmaceutical regulatory affairs, particularly in international markets
Broad background in pharmaceutical business and experience in various regulatory affairs areas (e.g., Global, European, International, Marketing Company, or health authority experience)
Strong project management skills
Excellent interpersonal and intercultural communication skills
Proficiency in local language and extensive working knowledge of English
Critical thinking and problem-solving skills
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