Assignment Details
Our client, a leading American Private Foundation, is looking to engage with a Regulatory Expert (Pharma).
Key Responsibilities:
Regulatory Strategy Development: Develop and implement regulatory strategies to support product development and ensure compliance with local and international regulations.
Submission Preparation: Prepare and submit high-quality regulatory documents, including INDs, NDAs, BLAs, and other submissions to regulatory authorities.
Compliance Oversight: Ensure ongoing compliance with regulatory requirements throughout the product lifecycle, including manufacturing, labeling, and post-marketing obligations.
Cross-Functional Collaboration: Work closely with cross-functional teams, including R&D, quality assurance, and clinical operations, to provide regulatory guidance and support.
Regulatory Intelligence: Monitor changes in regulations and guidelines, and provide insights and recommendations to senior management and project teams.
Stakeholder Engagement: Liaise with regulatory authorities and stakeholders to facilitate communication and resolve any regulatory issues or inquiries.
Training and Support: Provide training and mentorship to internal teams on regulatory processes, requirements, and best practices.
Skills Required
Key Skills:
1. In-depth knowledge of regulatory requirements and processes for pharmaceuticals in India and internationally.
2. Strong analytical and problem-solving skills, with the ability to interpret complex regulations.
3. Excellent communication and interpersonal abilities, fostering effective collaboration with diverse teams.
4. Proven track record of successful regulatory submissions and interactions with regulatory authorities.
5. Ability to manage multiple projects and priorities in a fast-paced environment.
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12 month(s)
10+ years 
On-Site
