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Engaged Employer

Abbott

Compare

4.1

based on 3.1k Reviews

Video summary

Proud winner of ABECA 2024 - AmbitionBox Employee Choice Awards

Top Rated Pharma Company - 2024

255 Abbott Jobs

Regulatory Project Head

Abbott Healthcare Pvt. Ltd

4.1

based on 3.1k Reviews

11-15 years

Mumbai

1 vacancy

Regulatory Project Head

Abbott

posted 3d ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy Regulatory Affairs Subject Matter Expertise Financial Due Diligence Process Improvement Licensing

Job Description

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.

JOB FAMILY: Regulatory Operations

LOCATION: India > Mumbai : BKC Building

SIGNIFICANT WORK ACTIVITIES: Keyboard use (greater or equal to 50% of the workday)

Employment Type: Full Time, Permanent

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