Abbott Regulatory Manager Recruitment 2020 - Apply Online

Abbott Regulatory Manager Recruitment 2020 – Apply Online

Abbott Regulatory Manager Recruitment 2020 Abbott Pharma Job Opening. Pharma Job Opening. Abbott invites undergraduate Pharma candidates for the post of Specialist. Check out all the details on Rasayanika.com

Job Title: ASSISTANT MANAGER– REGULATORY AFFAIRS

Location: REGULATORY AFFAIRS INDIA – MUMBAI

MINIMUM EDUCATION:

Bachelor’s degree in Pharmacy or life science-related subject with appropriate qualification.
Diploma in Regulatory Affairs preferred

MINIMUM EXPERIENCE / TRAINING REQUIRED:

  • Ideally, 5- 7 years of work experience, in the pharmaceutical industry
  • Previous experience in Regulatory Affairs, Global Labeling, PV, Medicines Development, Quality or related area(s)
  • Excellent command over spoken and written English is mandatory
  • Strong interpersonal skills to work with global teams is critical
  • Attentive to detail
  • Advanced word processing knowledge and experience with Microsoft Office products (Word, Excel and PowerPoint)

PREFERRED QUALIFICATIONS:

Knowledge and hands-on experience with labelling texts for both health professionals and patients.

GRDS Lead/Acting GRDS Lead:

Support GRDS Leads/Be a GRDS Lead to support assigned products for all non – CMC documents required by affiliates for regulatory submissions in a timely manner.

File maintenance:

Maintains accurate files of labelling change history and associated documents, using the available company electronic systems.

Promotional Material Release:

• Reviews and approves promotional materials with respect to CCDS and are compliant. globally applicable guidance and

• Ensures that promotional materials are accurate and compliant to internal codes of conduct, established regulations.

Affiliate Support:

Provide labelling support to affiliates including supporting renewals, geo expansions or any license maintenance activity.

Develops and maintains EPD Company Core Data Sheets (CCDS) and Company Core Patient Information (Master Package Leaflet) based on the available scientific knowledge, labeling guidelines and requirements within the Abbott EPD Labeling Process. Ensures CCDS information is based on Subject Matter Expert (SME) contribution.

Apply Online

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