Specialist- Commercial Regulatory Affairs

Overview

Prepare, submit and obtain approvals for import license applications, renewals and post-approval change applications, ensuring filings follow country-specific regulations, with a focus on India, Sri Lanka and other SWA countries. The role sits in the Commercial Regulatory Affairs Center of Excellence.

What you'll do

• Initiate, prepare and submit product import license applications, renewals and post-approval change applications, ensuring they follow country-specific regulations and guidelines, with a focus on India, Sri Lanka and other SWA countries.
• Coordinate with Business Unit Regulatory Affairs teams to request documents for the applications.
• Respond in a timely manner to queries raised by regulatory authorities regarding submitted applications.
• Ensure project timelines are met.
• Collaborate with cross-functional departments on products that require in-country testing data for registration.
• Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes.
• Provide regulatory guidance on preparation, review and approval of labeling and promotional materials as needed.
• Recognize potential problems, including ambiguous situations, by actively reviewing and analyzing internal and external factors.

What you'll need

• Degree in Science, Pharmacy or a related field.
• At least 7-8 years of relevant experience within the registration process in the medical devices or IVD industry.
• Well-versed understanding of India Medical Device Regulations 2017 and amendments.
• Experience working in a matrix organization and international environment.
• Experience handling projects with minimum supervision.
• IT literate with MS Office.
• Ability to multitask, prioritize and meet project deadlines in a timely manner.
• Ability to work in a self-directed manner to see issues through to completion.

Nice to have

• Good analytical and problem-solving skills, as well as interpersonal skills with emphasis on diplomacy, negotiation and ability to work in a team-based setting.
• Effective communication skills, flexibility, self-confidence, and achievement orientation with appropriate concern for quality.

Details

• Reports to the Manager, Commercial Regulatory Affairs (SWA).
• Part of the Commercial Regulatory Affairs Center of Excellence located in Delhi/NCR.
• On-site role.