Regulatory affairs formulation-Canada market Vipsa Talent Solutions

2.0 - 7.0 years

0 - 3 Lacs

hyderabad

Work from Office

Exp 2 yrs Exp in canada market Exp in formulation for 2 years

Posted 1 month ago

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Regulatory Affairs Associate Vipsa Talent Solutions

2.0 - 6.0 years

0 - 3 Lacs

hyderabad

Work from Office

Regulatory Affairs Associate (Formulation) Location: Hyderabad Experience: 2-8 years Education: Lifesciences Graduate Immediate Joiners preferred Skills: US, EU, Canada market experience, Formulation, CMC, ANDA, NDA filing, OSDs, Injectables

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Executive/Sr.Executive - Regulatory Affairs (Canada Market) Strides Pharma Science

1.0 - 5.0 years

4 - 8 Lacs

bengaluru

Work from Office

Responsible for compilation and assist team for projects and regulatory submissions by collating documents per regulatory requirements for Canada market for CMC and labelling aspects. Interpret and prepare response to the quality & administrative deficiencies as per regulatory requirement within defined timelines. Develop and implement regulatory CMC strategies to support post-approval changes (PACs), variations, and life cycle activities Co-ordinate with cross functional teams for document request, review, required for regulatory submission Upload and publish the documents in eCTD software required for regulatory submission Arranging and coordinating trainings within departments

Posted 2 months ago

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Team Leader - Regulatory Affairs (Canada Market) Strides Pharma Science

8.0 - 12.0 years

10 - 13 Lacs

bengaluru

Work from Office

Lead the preparation, review, and submission of high-quality regulatory CMC documentation for Canada market. Act as the primary regulatory liaison for CMC topics with internal stakeholders (e.g., manufacturing, quality, supply chain, R&D) and external partners (e.g., CMOs, CROs) Develop and implement regulatory CMC strategies to support post-approval changes (PACs), variations, and life cycle activities Review of change controls and categorize the changes as per the guideline requirements with the clear communication of documentation requirements Ensure regulatory compliance of CMC activities through robust planning and documentation in alignment with ICH guidelines and regional regulations ...

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Assistant Manager/ Manager Regulatory Affairs Emcure Pharmaceuticals Limited

7.0 - 11.0 years

0 Lacs

pune, maharashtra

On-site

As an Assistant Manager/Manager in Regulatory Affairs with 7-11 years of experience, you will report to the Head of Regulatory Affairs and be responsible for handling regulatory activities for the Canadian market. Your primary focus will be to develop regulatory strategies for submissions, assess changes, and manage the product life-cycle across various dosage forms. You will also be involved in compiling New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS), as well as conducting module-wise document reviews. Your role will encompass reviewing documents and artworks to ensure compliance with eCTD (electronic Common Technical Document) guidelines, as well as overseeing chang...

Posted 3 months ago

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AM-Immegration Bean Hr Consulting

5.0 - 10.0 years

10 - 13 Lacs

Gurugram

Hybrid

Key Objectives and Major Responsibilities: Manage the entire immigration process for employees, including various visa categories such as H-1B, H4, L-1A/L-1B for US, work permit for geos like Canadian, UK, Australia and Poland and applications for permanent residence Evaluate and assess employees' eligibility for immigration programs and identify strategies to overcome barriers Provide immigration consultation to employees and the business leadership team, addressing inquiries and resolving complex issues Oversee the preparation, submission, and final review of immigration petitions and other related documents Ensure compliance with all related regulations during the filing, renewal, and ame...

Posted 4 months ago

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