Regulatory Affairs Manager
4 weeks ago
Company Description
SurgeWay Biosciences Pvt Ltd is an established exporter of Pharmaceutical Drugs and Niche Healthcare Products. With a strong track record of domestic and international operations spanning 40 years, SurgeWay is led by a dynamic young team that brings a professional approach and long-term business growth outlook.
Our expertise in regulatory affairs, coupled with in-depth market analysis, ensures the success of our operations in various countries. We differentiate ourselves from competitors through quick turnaround time, excellent communication skills, efficient execution, and transparency in work.
Role Description
This is a full-time on-site role as a Regulatory Affairs Manager located in Bengaluru. The Regulatory Affairs Manager will be responsible for managing regulatory compliance, understanding and implementing regulatory requirements, preparing regulatory submissions, and establishing quality systems.
Roles & Responsibilities:
KEY DELIVERABLES:
- To review the Dossier compiled by the RA executives IN DEPTH, and to guide them to make the necessary corrections. THE OWNERSHIP OF THE FINAL DOSSIER SUBMITTED WILL BE YOURS.
- To have experience of preparation of dossier of all dosage forms (Tablets/Capsules/Dry Syrups/Liquid Injectables/ Dry Powder Injections)
>To prepare and compile registration dossiers as per the CTD / ACTD guidelines
> To review dossiers that are compiled by the manufacturing sites as well as other regulatory consultants and in-house RA team, and ensure maximum accuracy before submission.
> To prepare & review /check artwork, pack insert, SmPC, etc.
> To study Regulatory guidelines of assigned countries and to prepare a checklist / template for registration dossier.
> To verify specification of excipients, active, finished product, and packaging material and all required documents.
> Application, review, coordination, follow-up of legal documents COPP, FSC, etc.
> Maintain a Proper database w.r.t to master document dossier.
> To collect and verify all technical documents and information from various departments at the manufacturing site.
> Provide Regulatory support to various departments.
> Review follow-up and coordination for registration samples /WS and impurities required for analysis purposes.
> To reply to any queries raised by respective regulatory authorities, in a timely manner.
> To maintain and update Registration certificate /information in the regulatory database.
> Monitor and set timelines for license variations and renewal approvals.
> Write clear, accessible product labels and patient information leaflets.
Skills needed:
> Quality Review and In-depth review of dossiers submitted by the RA executives.
> Knowledge of standards of various international regulatory bodies of South East Asia and East Africa
> Organizational Skills- Work assignments, time management, working within strict time frames.
> Ability to solve regulatory queries & compliance matters.
> Knowledge of dossier types and filing requirements.
Requirements:
> Research experience in clinical work, toxicology, pharmaceuticals, and manufacturing techniques
> Prefer professionals with experience in Document (Process, Analytical) review, Dossier preparation and Submission- for ROW (Especially South East Asia and East African markets)
> Minimum Five years’ of experience in Pharma Regulatory Affairs will be preferred
> Immediate Joining or 15-day's Notice Period is preferred.
Candidate Profile:
> B.Pharma / D.Pharma / M.Pharm with relevant regulatory Experience
> Ability to grasp new concepts quickly
> Good communication skills in English
> Effective oral and written communication skills.
> Must be flexible and capable of managing personnel
> Must have a systematic approach to solving problems.
> Must be able to keep calm and make quick, clear decisions while coping with pressure.
> Must be able to understand the techniques and processes used
> Excellent PC skills, should be proficient with the usage of the internet as a tool to find useful information.
> Must be organized- timely, and with information/data.
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