Abbott Hiring Bachelors Degree in pharmacy for Manager regulatory affairs

Abbott Recruitment July 2020 Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology, or related subject for Manager regulatory affairs @ Mumbai . Interested candidates may apply online for selection as detailed below.

Abbott Hiring Bachelors Degree in pharmacy for Manager regulatory affairs

Important Vacancy details:

  • Post Name: Manager regulatory affairs
  • Education : Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology, or related subject
  • Experienced:8 years
  • Location: Mumbai
  • Salary : NA
  • Openings :NA

 Job Description: We have requirement for the post of Manager regulatory affairs in Abbott

. PRODUCT REGISTRATIONS / SUBMISSIONS

-Assists in product registrations by preparing/ requesting documentation needed for complex filings

-Employs project management skills to monitor activities and meet deadlines

-Prepares registration packages for routine filings

-Identifies and collects data needed

-Seeks expert advice and technical support for complex filings

-Prepares responses to deficiency letters

2. RELATIONSHIPS & CROSS FUNCTIONAL TEAM WORK

-May represent Regulatory CMC at relevant project meetings and communicates agreed RA position

-Monitors and communicates actual versus planned regulatory activities and timelines

-Identifies and communicates risks and issues impacting project progression

3. AFFILIATE COORDINATION

-Builds and maintains strong working relationships with Regional Product Leads and Affiliate colleagues

4. COMPLIANCE ACROSS LIFE-CYCLE

-Assesses and approves change requests and updates files accordingly

-Maintains awareness of legislation and current developments within specific area of business

-Works to assure products remain in compliance

5. STRATEGY

-Participates in the development of Regulatory CMC strategies for assigned products and projects

-Takes steps to identify, communicate, and mitigate Regulatory CMC risks

6. PROCESS IMPROVEMENT

-Identifies opportunities and suggests improvements

-Provides input into the development of position papers & work aids etc

7. HEALTH AGENCY INTERACTION

-Helps to prepare for Health Agency meetings as appropriate

8. LICENSING REVIEWS

-Can provide CMC Regulatory support for due diligence activities

9. TECHNICAL COMPETENCY

-Has general knowledge of technical/scientific principles and some specific knowledge of allocated products

-Has general knowledge of global and regional regulatory requirements

-Starts to develop specialist regulatory knowledge of assigned country or product-class requirements

Selection Process: The selection will be on the basis of Interview.

How to Apply Click here for full details and Apply Online

 

 

1 thought on “Abbott Hiring Bachelors Degree in pharmacy for Manager regulatory affairs”

  1. Hello sir, I have 1 year experience in Regulatory affairs department. Write now I am working in Ahmedabad Orbit pharmaceuticals. I want to know wheather i am illegible or not for the post which your company is looking for. Please let me know

    Reply

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