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

Posted 1 week ago

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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 3 weeks 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 Maintain awareness of and help implement changes related to product quality systems, quality investigations, risk assessments

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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 change controls and performing gap analysis for new product filings. Additionally, you will be tasked with maintaining product life cycles and collaborating with cross-functional departments to evaluate, approve, and implement change proposals, deviations, and escalations. Furthermore, you will be responsible for preparing internal guidance documents to support regulatory activities within the organization. This position is based in Pune and focuses on the Canadian market, encompassing all types of dosage forms. A degree in B.Pharm/M.Pharm is required to qualify for this role.,

Posted 1 month 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 amendment processes. Facilitate smooth internal transfers and international assignments for employees Ensure accuracy, adherence to timelines, and compliance with immigration regulations Develop and implement reporting mechanisms to track and analyze immigration data Provide insights and recommendations for program improvements and cost optimization based on data analysis. Collaborate with immigration service providers, law firms, and government officials to ensure effective and efficient delivery of immigration services. Handle audits conducted by government agencies related to immigration matters. Execute innovative and advanced approaches to immigration, keeping the organization at the forefront of immigration strategies and practices in the U.S. and Canada Key Capabilities and Competencies In-depth knowledge of global mobility principles, policies, tax, and immigration. Strong verbal, written and communication skills Self-driven, result-oriented, structured approach Proactive and takes initiative in seeing tasks to completion Ability to work and perform under pressure Ability to communicate and build partnerships with all levels of management and staff Demonstrated customer service and partnership skills. Analytical and continuous improvement mindset Strong organization and time management skills with the ability to multitask. Qualification and Experience Graduation/ Post Graduation, in a related field 6 to 8 years of post-qualification experience, with minimum 4 years of relevant experience in Immigration/ Global Mobility Experience in international locations, especially immigration support for US, UK, Canada, Europe and Australia Exposure to global business environments

Posted 2 months ago

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