Beckman Coulter, Inc. is a Danaher Corporation company that develops, manufactures, and markets products that simplify, automate, and innovate upon complex biomedical testing. It operates in two industries: Diagnostics and Life Sciences.
Post : Sr. RA Specialist
Job Description
The Sr. Specialist Regulatory Affairs will independently, with minimum supervision, initiate and prepare the regulatory submissions, interact with Business Units Regulatory affairs teams and interact with regulatory agencies/health authorities to obtain and maintain product approvals with a focus on India, Sri Lanka and other SWA Countries, as per the country specific regulations. Also responsible for initiating, requesting documents from Business Unit Regulatory Affairs team and submission to India regulatory Authority for any Post Approval change for the products approved in India. The associate shall also be responsible for meeting compliance with local and regulatory requirements for India and SWA region.
• Initiate, prepare and submit product Import license applications, renewals, and Post Approval change applications and ensure filings are following Country specific regulations and guidelines, with a focus on India, Sri Lanka and other SWA countries
• Responsible for the coordination with Business Units Regulatory Affairs team in requesting documents for the applications.
• Responsible for responding to the queries raised by the Regulatory authority against the application submitted.
• Responsible for ensuring in meeting the project timelines.
• Provide proactive regulatory intelligence in areas of a competitive nature and stay on top of changes in agency regulations and requirements.
• Collaborate with cross functional departments to complete the process for the products that require in-country testing data for registration purposes.
• Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes.
• Manage the Regulatory Stop Ships for the products registered and newly registered in India.
• Provide regulatory guidance with regards to preparation, review and approval of labeling and promotional materials as needed.
• Recognize potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors.
• Prepare formal written reports, PowerPoint presentations, and documents for distribution within work unit and regions.
• Assess corrective action to assure it prevents recurrence.
• Maintain the local and global registration database.
Candidate Profile
• Requires degree in a science / Pharmacy or related field.
• At least 8-10 years of relevant experience within the registration process in medical devices or IVD industry.
• In depth knowledge of Indian and other jurisdiction regulatory requirements.
• Experience in working in a matrix organization, international environment and experience in managing people.
• 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, achievement-oriented with appropriate concern for quality are highly desirable qualifications.
• Adaptability to work under time pressure & able to independently work within a team
• Strong interest for Customer Satisfaction
• IT literate with MS Office.
• Multitasks, prioritizes, and meets project deadlines in a timely manner
• Ability to work in a self-directed manner to see issues through to completion
Additional Information
Experience : 8-10 years
Qualification : Degree in a science / Pharmacy
Location : New Delhi India
Industry Type : Pharma
Functional Area : Quality & Regulatory Affairs
End Date : 10th July 2024
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