Senior Regulatory Affairs Consultant II (Future Opportunities)

Syner-GBiopharma

Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations.Full-TimeSenior

Salary not disclosed

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Job Details

Experience: Minimum seven (7) years

Requirements

Bachelor’s or Master’s degree required in sciences, Pharmacy, Biological sciences, Engineering, or related field, Advanced degree preferred.
Minimum seven (7) years of CMC post approval submissions or relevant experience, which may include regulatory, research, manufacturing, analytical methods development, quality control, or related fields.
Minimum 5 years’ experience in post approval CMC authoring and review of CMC sections in Module 1, 2, and 3 for the post-approval regulatory filings required.
Demonstrated superior oral and written communication skills, as well as interpersonal skills; detail-oriented and well organized.
Working knowledge of the US and European regulations and ICH guidances.
Extensive knowledge of pharmaceutical development, specifications, release and stability of drug products and substances.
Strong knowledge and experience of working in cGMP environment preferred.
Hands on experience in regulatory systems and tools for authoring and change controls assessment is a plus (i.e. EDMS, Veeva Vault, Trackwise).
Prior Supervisory experience in pharmaceutical industry is a plus.

Responsibilities

Demonstrating strong ownership, initiative and accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle.
Actively contributes to strategic discussions and decision-making processes.
Contribute to the development of CMC regulatory strategies and submission documents for post approval pharmaceutical products with the ability to execute tasks independently in accordance with US, EMA & global regulations and ICH guidance.
Execute regulatory strategies by leading the authoring and review of global CMC submissions and ancillary documentation to support post-approval supplements/variations, and responses to health authority questions using established business process and submissions tools.
Collaborate with CLIENT and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
Coordinate timely and accurate responses to the Regulatory agency questions (RTQs) on CMC content.
Perform regulatory reviews of technical/development documents such as certificate of analysis (CoA), analytical test methods, specifications, and stability protocol/report/data.
Assess and communicate potential regulatory risks and product mitigation strategies.
Identify, communicate and escalate potential regulatory issues to concerned CMC team/management, as needed.
May manage a team of two (2) to four (4) individual contributors in support of project execution.

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