HomeRegulatory AffairsAsst Manager Regulatory Affairs | Abbott Laboratories | Mumbai

Asst Manager Regulatory Affairs | Abbott Laboratories | Mumbai

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Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

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The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Position: Asst Manager – Regulatory Affairs

Location: BKC Building, Mumbai, Maharashtra, India

Job Description:

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 a specific areas 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 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 the 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

Qualification: B.Pharma/Lifescience with Diploma in Regulatory Affairs(Preferable)

Experience: 5- 7 years of relevant work experience

Contact Details:

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