Manager, Regulatory Affairs (Pre Approval) Amneal Pharmaceuticals

10.0 - 14.0 years

0 Lacs

ahmedabad, all india

On-site

Role Overview: As a Regulatory Affairs Specialist at the company, your main responsibility will be to prepare, review, and finalize regulatory strategies for complex products such as injectables, ophthalmic, otic, topical gel, DDCP, etc., along with 505(b)(2) products for regulated markets like the US, Canada, and EU. You will be drafting, reviewing, and finalizing various regulatory documents including Pre-ANDA/Pre-IND/ScA/Scientific meeting packages, controlled correspondences, and deficiency responses for complex products. Additionally, you will collaborate with cross-functional teams, meet management expectations regarding timelines and quality, and provide training to new team members o...

Posted 5 days ago

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Senior Executive, Regulatory Affairs, Pre Approval Injectable USA Market Amneal Pharmaceuticals

3.0 - 7.0 years

0 Lacs

ahmedabad, gujarat

On-site

Role Overview: As a Regulatory Affairs Specialist at Amneal, your primary responsibility will be to prepare regulatory strategies for complex products such as injectables, ophthalmic, otic, topical gel, and 505(b)(2) products for both the US and EU markets. You will be drafting Pre-ANDA/Pre-IND/ScA meeting packages, controlled correspondences, and deficiency responses for complex products. Additionally, you will review API and finished product in-vitro characterization reports, collaborate with cross-functional teams, and ensure compliance with regulatory standards. Key Responsibilities: - Prepare Regulatory strategies for Complex Products including injectables, peptides, microspheres, lipos...

Posted 2 months ago

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Product Design Manager Uberlife Consulting

9.0 - 14.0 years

37 - 55 Lacs

Bengaluru

Work from Office

Job Description We are looking for a Product Design Manager with a strong background in product design, an eye for pixel-perfect visual execution, and experience leading high-performing design teams. In this role, you will define and drive the design vision for our digital retail products, ensuring seamless, engaging, and accessible experiences for consumers. You will collaborate closely with product managers, engineers, and stakeholders to align design decisions with business goals while mentoring and guiding a team of designers to deliver high-quality work. While expertise in product design is the primary requirement, having experience in service design is a plus, as it can help shape end-...

Posted 6 months ago

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