Senior Regulatory Affairs Manager Contract
2 weeks ago
Quanta Consultancy Services Ltd is seeking a highly skilled Senior Regulatory Affairs Manager to join our team on a 12-month contract basis. As a leader in the pharmaceutical industry, our client is a globally recognized pioneer in Biotechnology, focusing on areas of high unmet medical need.
Key Responsibilities:- Develop and implement country-specific regulatory strategies for multiple products, providing feedback to internal teams on submission plans and execution.
- Ensure CMC regional issues impacting global regulatory strategy are considered, identifying risks and developing contingency strategies.
- Review and assess the preparation of M2 and 3 CMC components of filings, ensuring fitness for purpose in relevant countries.
- Manage regulatory CMC submissions (e.g., late-stage clinical trials, variations, extensions, and marketing applications) for products within the portfolio, in compliance with global filing plans and local regulatory requirements.
- Communicate regional needs for ensuring supply chain reliability and successful launch, collaborating with relevant stakeholders.
- Provide guidance on regulatory assessments of change control requests.
- Set project timeframes and priorities for products under responsibility, raising resource constraints as needed.
- Gather, consolidate, and analyze regulatory intelligence for international markets, supporting its application to product-specific activities.
- Share regulatory information and implications with stakeholders, providing advice on regional considerations.
- Maintain awareness of new and developing legislation, regulatory policy, and technical guidance relating to the company's products.
As a Senior Regulatory Affairs Manager, you will play a critical role in ensuring the successful launch of our client's products in the global market. If you have a strong background in regulatory affairs and a passion for the pharmaceutical industry, we encourage you to apply for this exciting opportunity.
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