Regulatory Affairs Coordinator at Abbott

Algiers, Algiers, Algeria

Abbott Logo
Not SpecifiedCompensation
Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, HealthcareIndustries

Requirements

  • Ability to collaborate with business development, marketing, manufacturing, quality assurance, development, logistics, marketing, medical departments, GPRA, local representatives, and relevant authorities
  • Knowledge of regulatory strategies, plans, dossiers, SOPs, and compliance procedures
  • Skills in preparing regulatory plans, dossiers for new products, renewals, variations, and promotional materials review/approval
  • Capability to ensure implementation within deadlines and agreed timeframes
  • Responsibility for SOP compliance, identifying improvements, relaying corporate values, and conducting training

Responsibilities

  • Collaborate with business development and marketing to establish short, medium, and long-term regulatory strategies for integrating new products
  • Prepare regulatory plans and ensure their implementation to achieve long-term objectives for product sales, market share, and profit
  • Work with manufacturing, quality assurance, and development teams to develop, approve, and implement labels within agreed timeframes
  • Coordinate with logistics department to organize sample deliveries within specified deadlines
  • Prepare regulatory dossiers for new products, renewals, and variations
  • Collaborate with marketing and medical departments to review and approve promotional materials per guidelines and deadlines
  • Work with GPRA to prepare dossiers for new products, renewals, and variations
  • Maintain effective communication with local representatives and relevant authorities
  • Ensure compliance with regulatory SOPs and identify improvement opportunities
  • Relay Abbott's corporate values and train new recruits
  • Ensure training is carried out as agreed

Skills

Regulatory Strategy
Regulatory Dossiers
SOP Compliance
Product Labeling
Promotional Materials Review
Regulatory Plans
Compliance

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters
1888Year Founded
IPOCompany Stage
HealthcareIndustries
10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.
Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.
Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.
Abbott's microfluidic devices streamline diagnostic processes efficiently.
Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.
Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.
Significant investments indicate strong market confidence in Abbott's healthcare solutions.

Land your dream remote job 3x faster with AI