About the role
JOB DESCRIPTION:
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 Equivalent
Associates Degree (± 13 years)
Experience/Background
Experience Experience Details
Minimum 1 year
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
MD Medical Devices
LOCATION:
India > New Delhi : New Friends Colony
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Skills & Tags
Aplyr's read
Abbott Laboratories is a leader in healthcare innovation, attracting professionals dedicated to advancing medical technology and patient care on a global scale.
What's promising
- •Abbott's diverse product range offers stability and growth opportunities.
- •Strong global presence enhances career mobility and international experience.
- •Commitment to R&D fosters a culture of innovation and learning.
What to watch
- •Regulatory challenges can impact product launch timelines.
- •High competition in the healthcare sector pressures market share.
- •Complex organizational structure may slow decision-making processes.
Why Abbott
- •Abbott's focus on both diagnostics and nutrition sets it apart from typical pharmaceutical companies.
- •Extensive global footprint provides unique cross-border project opportunities.
- •Abbott's investment in emerging markets offers growth in diverse regions.
Aplyr’s read is generated by AI from public sources. Was it useful?
About Abbott
Abbott Laboratories is a global healthcare company that develops and manufactures a wide range of medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals.
