Abbott Hiring Biology Candidates For Regulatory Affairs Role – Apply Now

Abbott Hiring Biology Candidates for Regulatory Affairs 

Abbott Hiring Biology Candidates for Regulatory Affairs to join their team in Mumbai as an EM Regulatory Partner. Interested Candidates check out the details below and Apply Online

Job title: EM REGULATORY PARTNER

Job Location: Mumbai, India

Job Category: Regulatory Affairs

Job Type: Full Time

CORE JOB RESPONSIBILITIES:

• Provide strategic input into the development of defined tasks for assigned products/projects seeking guidance where appropriate.
• Provide input into global strategic plans as appropriate.
• Monitor actual vs. planned activities and timelines and identify issues impacting project progression.
• Assist with the preparation and review of technical strategic regulatory documentation for agency submission.
• Responsible for ensuring accuracy and quality of documentation.

POSITION ACCOUNTABILITY/SCOPE:

• EFFECTIVE INTERFACE WITHIN REGION AND BROADER ABBOTT ORGANIZATION
• Works primarily with Regional organization (commercial, supply, quality.etc), Affiliate RA staff and Divisional RA contacts.

PROJECT OR GEOGRAPHIC OR TA ACCOUNTABILITY

• Assist with projects  within one or more therapeutic areas.
• Assist with geographic intelligence, liaison and affiliate support as provided and directed by manager – this role will primarily interact with Russia, CIS and Turkey – thus Russian or Turkish language skills is an advantageous
• Project assignments and strategic direction are provided by manager.
• Routine supervision of project activities is required

SCOPE OF ACCOUNTABILITY (BUDGET, RESOURCES, PLANNING)

• Accountable for assigned project/task scope; completion with scheduled completion date
• No direct budgetary responsibility
• Adheres to departmental guidelines on expenses
• Identifies opportunities for cost savings

RESOLUTION, PREDICTION OF REGULATORY ISSUES

• Resolves current issues, learns and adjusts based on prior results.

AWARENESS AND APPLICATION OF REGULATORY INTELLIGENCE

• Maintain awareness of new draft legislation and guidelines.

IMPACT ON REGULATORY POLICY AND REGULATIONS

• Follows policy to ensure standard interpretation of regulations for defined project or task.

MINIMUM EDUCATION: Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology, or related subject

APPLY ONLINE

Here are interview questions along with answers:

1. Question: Can you describe your experience in providing strategic input for regulatory affairs projects? Answer: In my previous role as a Regulatory Affairs Specialist at XYZ Pharmaceuticals, I actively contributed to the development of strategic plans for regulatory submissions. I collaborated with cross-functional teams to ensure alignment between regulatory requirements and project goals. By monitoring activities and timelines, I identified potential issues and provided guidance to keep the projects on track. I believe my experience in strategic regulatory input will enable me to contribute effectively to the assigned products/projects in this role.

2. Question: How do you ensure the accuracy and quality of regulatory documentation? Answer: Accuracy and quality are critical in regulatory documentation. To ensure this, I follow a meticulous approach. I review and verify all information, cross-checking data from multiple sources when necessary. I pay close attention to detail and adhere to established regulatory standards and guidelines. Additionally, I collaborate with subject matter experts to gather insights and feedback, ensuring that the documentation meets the required accuracy and quality standards.

3. Question: How do you stay updated on new regulations and guidelines in the regulatory affairs field? Answer: Staying updated on new regulations and guidelines is essential in the dynamic field of regulatory affairs. I make it a priority to maintain awareness by actively monitoring regulatory authorities’ websites, attending industry conferences, and participating in relevant professional networks. Additionally, I subscribe to regulatory intelligence platforms and publications to receive timely updates. This proactive approach allows me to stay informed about new draft legislation and guidelines that could impact our products and projects.

4. Question: Can you provide an example of how you resolved a challenging regulatory issue in your previous role? Answer: In a previous project, we faced a regulatory challenge regarding the approval of a new medical device. The regulatory authority raised concerns about the product’s safety data. To address this issue, I led a cross-functional team to conduct a comprehensive safety assessment and compiled additional supporting evidence. I then engaged in direct communication with the regulatory authority, presenting our findings and addressing their concerns effectively. Through this collaborative effort, we successfully resolved the regulatory issue and obtained the necessary approval.

5. Question: How do you ensure compliance with regulatory policies and regulations in your work? Answer: Compliance with regulatory policies and regulations is a top priority in my work. I ensure compliance by closely following established procedures and guidelines specific to the project or task at hand. I stay updated on regulatory requirements and standards, seeking clarifications when needed. Additionally, I maintain open communication with internal stakeholders, leveraging their expertise to interpret regulations accurately. By adhering to regulatory policies and regulations, I ensure that our projects are in line with the required standards.

Editor’s Note: Abbott Hiring Biology Candidates for Regulatory Affairs. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.