Sr. RA Specialist at Abbott Pediatrics

Shanghai, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

04 Apr, 26

Salary

0.0

Posted On

04 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Product Registration, Regulatory Strategy, Risk Management, Chemistry Manufacturing Control, Regulatory Liaison, Approval Processes, Technical Labeling, Manufacturing Changes, Line Extensions, Experience Reports, Agency Interaction, Development Teams, Marketing Teams, Biologics, Medical Devices

Industry

Hospitals and Health Care

Description

JOB DESCRIPTION: MAIN PURPOSE OF ROLE Summarize the main purpose of the role. Experienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in the area of Regulatory Affairs. Requires capacity to apply skills/knowledge within the context of specific needs or requirements. MAIN RESPONSIBILITIES • As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. • Interacts with regulatory agency to expedite approval of pending registration. • Serves as regulatory liaison throughout product lifecycle. • Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC). • Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products. • Serves as regulatory representative to marketing, research teams and regulatory agencies. • Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. QUALIFICATIONS Education Education Level Major/Field of Study Or Education Level Associates Degree (± 13 years) ☐ Experience/Background Experience Experience Details Minimum 1 year The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: ADC Diabetes Care LOCATION: China > Shanghai : 388 W. Nanjing Road, Ciros Plaza ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter

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Responsibilities

The Sr. RA Specialist directs the development of product registration submissions and interacts with regulatory agencies to expedite approvals. They serve as a regulatory liaison throughout the product lifecycle and advise teams on compliance and regulatory strategies.