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264 Abbott Jobs
Regulatory Project Head
Abbott
posted 2hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Primary Job Function:
Independently:
1. Product registrations /Submissions
-Leads and coordinates project registrations for complex filings, including new product introductions
-Identifies and collects data needed, or delegates where appropriate
-Seeks and evaluates expert advice and technical support where necessary
-Prepares responses to deficiency letters
2. Relationships Cross Functional team work
-Represents Regulatory Affairs at relevant meetings and presents agreed RA position
-Provides expert advice and technical support to cross-functional colleagues
-Monitors actual versus planned activities and timelines.
-Proactively identifies, communicates and mitigates risks and issues impacting project progression.
3. Affiliate Coordination
-Maintains strong working relationships with Regional Product leads and Affiliate colleagues
-Finds ways to improve ways of working and knowledge sharing
4. Compliance across Life-Cycle
-Assesses and approves change requests and ensures files are updated accordingly
-Has expert knowledge of legislation and current developments across different areas of business
-Acts as a subject matter expert
-Manages corrective action plans and drives to completion within agreed timelines
5. Strategy
-Leads and coordinates the development of regulatory product strategies for assigned products and projects
-Identifies, communicates and mitigates regulatory risks
6. Process Improvement
-Identifies opportunities and proactively takes steps to implement improvements
-Leads the development of position papers work aids etc
7. Health Agency Interaction
-Takes a leading role in preparing for and attending Health Agency meetings as appropriate
-Liaises (including acting as the single point of contact if necessary) with Notified Bodies and other medical device organisations (may not be applicable to all staff)
8. Licensing Reviews
-Leads and coordinates regulatory due diligence activities for assigned projects
9. Technical competency
-Has expert knowledge of global regulatory requirements
-Has specialist regulatory knowledge across multiple countries, region, product class requirements
-Has expert knowledge across product protfolios
-Ensures knowledge remains current
CORE COMPETENCIES
Anticipation
-Develops scenario and contingency plans that ensure achievement for results under changing conditions and situations
-Proactively implements change to mitigate risks, solve issues or improve processes and ways of working.
-Actively gathers customer inputs in order to anticipate and fulfill their needs and requirements
-Manages internal/external stakeholders to identify and address issues
-Understands the situation or audience and adjusts approach to achieve desired outcomes
Adaptability
-Effectively prioritizes and plans long-term (months/years) work tasks and projects, including the work of others
-Has big picture thinking to Identify synergies and opportunities across the organisation
-Regularly reviews commitments and re-prioritises activities or negotiates timelines as necessary
-Reacts quickly to solve problems and issues as they arise
-Provides guidance, advice and mentoring to colleagues
Initiative
-Understands the organisation and the roles of other functions
-Proactively anticipates, mitigates and avoids problems and issues
-Proactively seeks feedback from manager and team members and adapts behaviour to improve performance
-Maintains strong customer focus.
Innovation
-Uses intrapreneurial skills to identify and execute new or unique ways to address work problems and opportunities
-Creates an environment of experimentation and uses failure as an opportunity to learn and take alternate action
-Challenges current thinking and generates new ideas. Encourages others to do the same
-Integrates information from multiple sources to generate unique insights or new solutions that increase competitiveness
-Leverages diversity of people and thinking to create a competitive advantage
-Collaborates across boundaries to create cross-business 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
-Uses leadership skills drives completion of individual and shared goals and to develop the skills of others
LEADERSHIP COMPETENCIES
Set Vision and Strategy
-Uses influencing and negotiation skills to drive strategic alignment of key cross-functional stakeholders
-Drives the generation of robust regulatory strategies for complex global projects
Build Organization and Inspire People
-Mentors junior team members
-Provides training and support on areas of subject matter expertise
-Demonstrates strong leadership skills every day and encourages the same others to do the same
-Provides insight, knowledge and leadership to improve functional area and build the business
Drive Results
-Displays energy and persistence to drive the organization forward
-Delivers what is promised; holds self and others accountable for results, commitments and behaviors
-Takes appropriate accountability for failure; does not blame others
-Takes action in a timely manner, with urgency or caution as appropriate, but always in a planful way
-Balances short-term and long-term priorities and maximizes the opportunities for both
-Addresses organizational or cultural barriers that could prevent success
Make Difficult Decisions
-Identifies crisis situations and elevates appropriately
Encourage an Open Environment and Knowledge Sharing
-Provides accurate, frequent and constructive feedback to subordinates, peers and leaders
-Openly shares information with peers and managers
-Challenges and expects to be challenged
Supervisory/Management Responsibilities:
Direct Reports : None (individual contributor)
Indirect Reports: None (individual contributor)
Minimum Education:
Bachelors Degree in pharmacy, biology, chemistry, pharmacology, or related subject
Minimum Experience/Training Required:
10+ years experience in Regulatory Affairs, RD, Manufacturing or related area. By exception, less experience is acceptable, e.g. if supplemented by other relevant knowledge such as a higher degree in a related discipline.
Employment Type: Full Time, Permanent
Read full job descriptionPrepare for Head - Projects roles with real interview advice
What people at Abbott are saying
Head - Projects salary at Abbott
reported by
3
employees
with 10-20
years exp.
₹50
L/yr - ₹65
L/yr
105%
more
than the average Head - Projects Salary in India
View more details
What Abbott employees are saying about work life
based on 3k employees
Flexible timing
Monday to Saturday
Within city
Day Shift
Abbott Benefits
Submitted by Company
Healthcare Incentive program Vacation & Holidays Life insurance
Submitted by Employees
Health Insurance 
Job Training 
Soft Skill Training 
Free Transport 
Work From Home 
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Abbott Mumbai Office Locations
Mumbai Office
Headquarter
271, Business Park, Model Industrial Colony, Off Aarey Road, Goregaon (E)
Mumbai
Maharashtra 400063
Maharashtra 400063
Mumbai Office
Abbott Laboratories (India) Limited, Padmaja Apartment-a, Yari Road, Versova, Versova
Mumbai
Maharashtra 400061
Maharashtra 400061
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