Regulatory Compliance Specialist
3 weeks ago
At Advanov Pharma Pvt Ltd, we are seeking a highly skilled Regulatory Compliance Specialist to join our team. This is a senior-level role that requires strong regulatory knowledge and expertise in managing and coordinating regulatory activities to ensure compliance with global, regional, and local regulatory requirements.
Key Responsibilities:- Regulatory Strategy and Compliance
- Develop and implement regulatory strategies for new and existing products in alignment with global regulatory requirements.
- Ensure regulatory compliance for products in accordance with guidelines from authorities such as Health Canada, INVIMA, ANVISA, EMA, COFEPRESS, and other relevant regional agencies.
- Monitor changes in regulatory guidelines, industry standards, and market conditions, and assess their impact on the organization's products and regulatory strategy.
- Advise internal teams (R&D, manufacturing, labelling, clinical, etc.) on regulatory requirements related to product development, manufacturing, and advertising.
- Regulatory Submissions and Approvals
- Prepare, review, and submit regulatory dossiers (e.g., IND, NDA, ANDA, MAAs) for product approval and market authorization in compliance with regulatory standards.
- Coordinate and lead responses to regulatory authorities' queries, ensuring timely and accurate replies.
- Assist in the preparation and submission of updates, renewals, amendments, and variations in accordance with product lifecycle management.
- Cross-functional Collaboration
- Work closely with external teams (R&D, QA/QC, clinical, and manufacturing) to ensure the timely and compliant execution of product development plans.
- Provide regulatory guidance to product development teams to ensure that regulatory requirements are considered at each stage of the product lifecycle.
- Collaborate with business development, marketing, and sales teams to understand market needs and regulatory requirements for new and existing products.
The ideal candidate will have a Bachelor's or master's degree in pharmacy, Life Sciences, or a related field, and minimum 6-8 years of experience in regulatory affairs within the pharmaceutical or life sciences industry.
The estimated salary for this position is around $120,000 - $180,000 per year, depending on experience and qualifications.
We offer a competitive benefits package, including health insurance, retirement plan, and paid time off.
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