Offers “Abbott”

days ago Abbott

Assistant Manager / Manager Regulatory Affairs

  • Internship
  • Navi Mumbai, India
  • Project / Product management

Job description

     

JOB DESCRIPTION:

Primary Job Function:

With Manager Support:-

1. 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

CORE COMPETENCIES

Adaptability

-Effectively prioritizes short-term (days) to mid-term (weeks) work tasks

-Works with manager to regularly review work commitments and activities

-Reacts quickly to solve problems and issues when they arise

Initiative

-Takes steps to anticipate, mitigate and avoid problems and issues

-Seeks feedback from manager and team members and adapts behaviour to improve performance

Innovation

-Develops an intrapreneurial mindset to identify new or unique ways to address work problems or opportunities

Integrity

-Delivers high quality results.

-Meets agreed deadlines.

-Exhibits honesty and presents complete impartial information.

-Displays consistency between words and actions.

-Acknowledges and responds constructively to failures and mistakes.

-Expresses dissatisfaction constructively, without over-reacting.

Teamwork

-Actively interacts with colleagues to drive completion of team and shared goals

LEADERSHIP COMPETENCIES

Set Vision and Strategy

-Takes a major role in generating robust Regulatory CMC strategies supporting right-first-time submissions

Build Organization and Inspire People

-Mentors junior team members

-Starts to develop own leadership skills and practices these skills in day to day work

Drive Results

-Complete goals according to agreed deadlines

Make Difficult Decisions

-Provides input into decision-making within scope of project/product responsibilities

Encourage an Open Environment and Knowledge Sharing

-Provides honest, accurate feedback to colleagues, whether positive or negative

-Not afraid to challenge peers and be challenged

-Openly shares information with peers

Supervisory/Management Responsibilities:

Direct Reports              None (individual contributor)

Indirect Reports:           None (individual contributor)

Minimum Education:

Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject

Minimum Experience/Training Required:

A minimum of 8 years of experience in Regulatory Affairs, R&D, Manufacturing or related areas

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

EPD Established Pharma

        

LOCATION:

India > Mumbai : BKC Building

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 10 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)