Opening for Asst Manager Global Regulatory Affairs CMC in for Hospitals & Healthcare - Andheri location (Contract)

Job Description:

Designation: Asst Manager Global Regulatory Affairs CMC (On a Contract )

Department: Global Regulatory Affairs CMC

Contract Duration: 12 Months will be working on Talisman payroll (Not renewable)

Location: MIDC Andheri East, Mumbai.

Working Day: Monday To Friday

Time: 9 A.M To 6 P.M

Primary Job Function:

1. Product registrations / Submissions
-Assists in product registrations by preparing/ requesting documentation needed for filings
-Prepares registration packages for routine filings
-Identifies and collects data needed
-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

3. Affiliate Coordination
-Works with Regional Product Leads and Affiliate colleagues

4. Compliance across Life-Cycle
-Assesses change requests and updates files accordingly
-Builds awareness of legislation and current developments within specific area of business
-Works to assure products remain in compliance

5. Strategy
-Provides input into the generation of Regulatory CMC strategies for assigned products and projects
-Works with manager to identify, communicate, and mitigate Regulatory CMC risks

6. Process Improvement
-Identifies opportunities and suggests improvements
-Collects information to support 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
-Has general knowledge of global and regional regulatory requirements

CORE COMPETENCIES

Adaptability
-Works with manager to prioritize short-term (days) work tasks
-Works with manager to regularly review work commitments and activities
-Reacts quickly to solve problems and issues when they arise
CORE COMPETENCIES

Adaptability
-Works with manager to prioritize short-term (days) work tasks
-Works with manager to regularly review work commitments and activities
-Reacts quickly to solve problems and issues when they arise

Initiative
-Attempts to anticipate, mitigate and avoid problems and issues
-Seeks feedback from manager and team members and adapts behaviour to improve performance

Innovation
-Starts to develop 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
-Interacts with colleagues to complete team and shared goals

LEADERSHIP COMPETENCIES

Set Vision and Strategy
-Contributes to generation of robust Regulatory CMC strategies supporting right-first-time submissions

Build Organization and Inspire People
-Shares knowledge and previous experience with peers

Drive Results
-Completes goals according to agreed deadlines

Make Difficult Decisions
-Provides information to help with 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 10 years of experience in Global Regulatory Affairs for Emerging markets (Except US and Europe)