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Senior Manager - Regulatory Affairs
Abbott
posted 1 day ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Primary Job Function:
With minimal Manager Support:-
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 and communicates risks and issues impacting project progression.
3. Affiliate Coordination
- Maintains strong working relationships with Regional Product leads and Affiliate colleagues
4. Compliance across Life-Cycle
-Assesses and approves change requests and ensures files are updated accordingly
-Has expert knowledge of legislation and current developments within specific area of business
-Acts as a subject matter expert within specific area of business
-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
-Independently identifies opportunities and suggests improvements for resolution
-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 of assigned country, region, product class requirements
-Has expert knowledge of allocated products
-Takes active steps to keep knowledge current
CORE COMPETENCIES
Anticipation
-Develops scenario and contingency plans that ensure achievement for results under changing conditions and situations
-Takes initiative to implement 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
-Develops 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 and advice to colleagues
Initiative
-Has a clear understanding of 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
-Actively drives completion of individual and shared goals
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 leadership skills in day to day work and encourages the same traits in others
-Provides insight, knowledge and leadership to improve functional area and build the business
-Develops and demonstrates strong leadership skills and encourages others to do the same
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
-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, R&D, 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 description
What people at Abbott are saying
Rating based on 2 Senior Manager- Regulatory Affairs
reviews
Anonymous · Legal & Regulatory
in Mumbai
Likes
Abbott helps every individual to grow in their careers through Individual Development Plan. It helps to achieve your career path. Respect to everyone individuals. SLT team is very supportive.
- Salary - Excellent
+6 more
Dislikes
Don't have any dislike
Senior Manager- Regulatory Affairs salary at Abbott
reported by
7
employees
with 12-20
years exp.
₹25
L/yr - ₹36
L/yr
15%
more
than the average Senior Manager- Regulatory Affairs Salary in India
View more details
What Abbott employees are saying about work life
based on 3.3k 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 
Education Assistance 
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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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