Drug Regulatory Affairs Salary in India, DRA Officer, Executive, Manager, Analyst Career Growth & Job Profile, Role in DRA
Job Profile, Role & Responsibilities of DRA official in any company
The Senior RA Executive shall report to the Head of QA/RA, and is responsible to assist him in the following areas:
· Leading new product registrations and license renewals in various regulated/semi regulated countries
· Compliance for international as well as local regulations for various class of medical devices in the regions where they are distributed.
· Preparing the responses against the queries raised during the registration of medical device products.
· To Lead QA/RA team and ensure the preparation and maintenance of regulatory/quality SOPs within the company
· Have the joint responsibility to develop, facilitate and execute comprehensive regulatory strategies through all phases of development and product life cycle, to accelerate and ensure successful product registrations and provides regulatory assessment and supports Change Control Assessment
· Oversee maintenance of product quality and compliance through the Quality Assurance functions as well as management of the Quality Management System and compliance processes
· Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects
· Keep abreast of International legislation and guidelines of current product line in India
· Compliance with respect to internal/external audits meeting regulatory/ accreditation requirements
· Reviewing current accreditation/regulatory requirement, performing gap analysis and ensuring compliance to current requirements
· Provide product specific Regulatory strategies to mitigate risk; works in conjunction with production, RA & QA team to provide advice on process and labelling changes
· Review of SOPs, BPRs, specifications and change control to ensure compliance
· Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks
· Drives resolution of issues, communicates issues, impact and outcomes to the management team
· Responsible for ensuring compliance to the submission standards, procedures and policies in India
· Support Commercial Department in business development such as product evaluation and pre-launch activities
· Support Marketing/sales department for product review, product function training, catalogue preparation, content management, field queries resolution etc.
Qualifications
● More than 2 years of experience in technical documentation, regulatory affairs and quality assurance in the medical device industry
● Bachelor’s degree in relevant field (Pharmacy, Lifesciences). Master’s is desirable
● Ethical behaviour and high level of integrity
● Good teamwork, independent and committed to works across functional department
● Possess good negotiation and dispute resolution skills
● Demonstrated experience operating in a regulated environment
● Ability to read, analyse and interpret governmental regulations & reports, scientific or clinical publications and data
● Ability to write reports, business correspondence, and quality procedures
● Must be able to effectively operate in a PC environment, be familiar with Microsoft Word, Excel, PowerPoint, Access, Outlook and Internet data search utilities
Find out various companies for salary estimate of DRA executive from freshers to experience category
Salary
The estimated salary for a Drug Regulatory Affairs Specialist is ₹3,58,585 per year. This number represents the median, which is the midpoint of the ranges from salary estimate (portals like glassdoor, Ambitionbox, 6figr), proprietary Total Pay Estimate model and based on salaries collected from their users. The “Most Likely Range” represents values that exist within the 25th and 75th percentile of all pay data available for this role.
Typical paths for career advancement in regulatory affairs
The following are examples of typical career advancement chances in regulatory affairs:
Regulatory Officer/ Executive / Associate
Senior Associate
Manager
Senior Manager
Director
Senior Director
Head of Department
Vice President
A Regulatory Affairs role will vary depending on the level of seniority. However, a few examples of what a role within this sector could entail are set out below:
- Ensuring that every product that is generated complies with laws.
- Preparing technical documentation and dossiers for submission.
- Overseeing the filing process as well as any post-marketing initiatives, such as post-market monitoring and remediation.
- Corresponding with authorities that oversee regulations.
- Obtaining, analysing, and assessing important data.
How to grow your career in DRA
You can take on a number of other responsibilities in addition to these qualities to help progress your career:
Acquire senior-level mentoring experience
It is advised that you obtain mentoring experience if your goal is to advance into a senior-level role. More duties will be assigned to you as you go up the hierarchical ladder, and these will involve educating junior level applicants about your expertise and best practices. It’s critical that you possess the abilities needed to impart your knowledge and experience to trainees in a way that will help them become proficient in their roles.
Sandwich positioning
University students can gain work experience through a sandwich placement. In essence, this chance gives a student a limited time of employment in a certain field.
Experience managing stakeholders
In a sense, regulatory affairs specialists serve as a liaison between employers, their goods, and the regulatory agencies. Candidates must therefore be able to build strong relationships and communicate clearly with important stakeholders. This kind of experience can only be gathered through face-to-face conversations with stakeholders. But as time goes on, your experiences and expertise will expand.
The certification from the Organisation for Professionals in Regulatory Affairs (TOPRA)
The professional membership association TOPRA supports and advocates for people who work in the field of regulatory affairs. In addition, TOPRA offers CPD certifications to industry professionals. This could help you advance in your profession by enhancing your skills and accelerating the achievement of your objectives.