IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. IQVIA Regulatory Affairs Opening. Life Science RA job. Job details are attached below. Apply online for Life Science RA job.
Job role – Regulatory Affairs Manager
Primary Location: Bangalore, India
Job ID – R1384822
Job description –
The Manager, of Regulatory Affairs International supports ambitious geographical expansion plans. The position will support the registration of existing portfolio products into new territories and register several development projects in the international region. This role is key to driving both the Regulatory strategy and execution.
Key Responsibilities/Scope of the Job –
- Represent International region in Global Regulatory Team and other cross-functional forums, for assigned products
- Develop International regulatory strategies and filing plans, in partnership with the
- Global Regulatory Lead, and country leads, for assigned products in development
- Plan and create a core dossier for International, in partnership with cross-functional teams, for assigned products
- Develop regulatory strategies in assigned countries, in partnership with local Regulatory teams
- Manage, plan and direct all aspects for the successful preparation, submission and timely approval of marketing applications and post-approval management for assigned countries
- Provide strategic guidance on regulations and changes in assigned countries
- Support interactions with Health Authorities in assigned countries
Position Qualifications
Education/Learning Experience/Work Experience –
- A University Degree in Life Sciences is required with 5 to 7 years of industry experience, of which at least 3 years of experience within Regulatory Affairs (registration, development, maintenance)
- Experience of regulatory requirements in countries outside the US and Europe
- Very good knowledge in written and oral English is required, knowledge of any other languages would be an asset
- Experience from leading projects and cross-functional teams
Personal Attributes
- A strong team player, with the ability to work effectively in a team setting and interact with people of different cultural, seniority and functional backgrounds
- Highly self-motivated and able to drive activities
- Excellent communication skills
- The suitable candidate should demonstrate the values; Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership
- Ensure exemplary behaviour, ethics and transparency within the Company and with regulatory agencies
Hello there, friends! We’ve gathered a set of interview questions and their corresponding answers to assist you in your interview preparations. We hope this resource helps you excel in your upcoming interview for the Life Science RA job.
Can you describe your experience in developing regulatory strategies for international markets and collaborating with cross-functional teams?
Sample Answer: In my previous role as a Regulatory Affairs Manager, I had the opportunity to lead the development of regulatory strategies for international expansion. I worked closely with cross-functional teams to assess regulatory requirements in various countries and adapt our strategies accordingly. One notable achievement was successfully registering several development projects in international markets, which required meticulous planning and coordination with both global and local regulatory teams.
How do you stay updated on regulatory requirements in countries outside the US and Europe, and how do you ensure compliance with these requirements?
Sample Answer: Staying updated on international regulatory requirements is essential in my role. I regularly monitor regulatory changes through resources like government websites, industry publications, and professional networks. Additionally, I maintain open communication channels with our local regulatory teams in different countries to ensure we are aligned with the latest requirements. This proactive approach helps us remain compliant and avoid any regulatory issues.
Can you provide an example of a challenging situation where you had to interact with Health Authorities in an international market, and how did you handle it?
Sample Answer: Certainly. In a previous role, we faced a complex regulatory issue in an international market that required direct interaction with Health Authorities. I led the engagement by carefully preparing all necessary documentation, conducting thorough research on local regulations, and collaborating closely with our legal and compliance teams. By presenting a clear and well-prepared case, we were able to address their concerns, resolve the issue, and maintain a positive working relationship with the Health Authority.
How do you ensure effective communication and collaboration with cross-functional teams, especially when dealing with complex regulatory projects?
Sample Answer: Effective communication and collaboration are crucial for successful regulatory projects. I believe in establishing clear communication channels, setting expectations, and fostering a collaborative environment. Regular cross-functional meetings, project timelines, and defined roles and responsibilities help ensure everyone is on the same page. Additionally, I emphasize the importance of open and transparent communication to address any challenges or issues promptly.
Can you describe a situation where you demonstrated the values of “Care for our patients, for our colleagues and for our company” in your work?
Sample Answer: One of the values I hold dear is “Care for our patients, for our colleagues and for our company.” In a previous role, we faced a delay in the regulatory approval process that could have impacted patient access to a critical medication. I worked closely with my team to expedite the submission process and collaborated with colleagues from different departments to ensure patients received the necessary treatment without interruption. This experience reinforced the importance of caring for both patients and colleagues while maintaining the company’s integrity.
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