LATEST PHARMACY JOB AT ABBOTT – CMC Assistant Manager Role – APPLY NOW

CMC ASSISTANT MANAGER AT ABBOTT REQUIREMENT 

Abbott, a renowned global healthcare company, is seeking a highly motivated individual to join their team in Mumbai, India, as a CMC Assistant Manager in the Regulatory Affairs category. With a focus on improving people’s lives through the development and marketing of pharmaceuticals, medical devices, diagnostics, and nutrition products, Abbott has established itself as a leader in the industry. As a CMC Assistant Manager, you will play a pivotal role in ensuring regulatory compliance for Abbott’s pharmaceutical products.

COMPANY : ABBOTT

ROLE : CMC ASSISTANT MANAGER

LOCATION : MUMBAI, INDIA

CATEGORY : REGULATORY AFFAIRS

EDUCATION : Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology, or related subject. A relevant master’s degree is preferred

PRIMARY JOB FUNCTION OF CMC ASSISTANT MANAGER AT ABBOTT

This is a newly created position to support CMC activities for local and regional products within the Emerging Markets (EM) to ensure activities are completed consistently in a timely manner in accordance with Abbott’s policies, procedures and local regulations.

Overall scope consists of providing CMC support to Regional and Affiliate Product Leads, primarily in:

1. CMC WRITING FOR LOCAL AND REGIONAL PRODUCTS

• Drafts scientific CMC, and regulatory documents that conform to regional/local/global regulatory requirements, industry standards, and accepted templates.
• Extracts and summarizes scientific information from development reports and identify details required for regulatory submissions.
• Prepares, coordinates and manages the review and approval of documents by:
• Supporting the operation of the integrated review process
• Performing comment reconciliation to address and resolve issues
• Editing and creating updated drafts for the next phase of review in accordance with the established timelines
• Complies with Abbott’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of Abbott

2. RELATIONSHIPS & CROSS FUNCTIONAL TEAM WORK

• Compiles and approves regulatory documents in collaboration with technical and operational stakeholders
• Manages review and approval regulatory documents; engages members of relevant stakeholders to address and resolve issues in accordance with established timelines.
• Monitors and communicates actual versus planned regulatory activities and timelines
  Identifies and communicates risks and issues impacting project progression
• Maintains awareness of regulatory legislation and assesses its regional impact on business and Emerging Market Regulatory Affairs

3. COORDINATION

• Builds and maintains strong working relationships with Regional and Affiliate Product Leads
• Provides accurate feedback to colleagues

4. COMPLIANCE ACROSS LIFE-CYCLE

• Ensures continuous compliance in alignment with Abbott procedures and regulations
• Maintains awareness of legislation and implement changes as relevant
• Ensure compliance with records retention (archiving) policy

5. STRATEGY

• Takes steps to identify, communicate, and mitigate Regulatory CMC risks

6. PROCESS IMPROVEMENT

• Support in streamlining and harmonizing operational related processes,
• Creates SOP delivers training as applicable.
• Identifies opportunities and suggestions for continuous improvements

CORE COMPETENCIES REQUIRED FOR THE ROLE OF CMC ASSISTANT MANAGER AT ABBOTT:

TECHNICAL

• Demonstrates general knowledge of technical/scientific principles and some specific knowledge of allocated products
• Shows general knowledge of global and regional regulatory requirements

ADAPTABILITY

• Shows flexibility and ability to work under pressure
• Reacts quickly to solve problems and issues when they arise
• Manages priorities and align with manager in case of conflicts/priorities

INTEGRITY

• Delivers high quality results.
• Meets agreed deadlines.
• Displays consistency

INITIATIVE

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

INNOVATION

• Develop an intrapreneurial mindset to identify new or unique ways to address work problems or opportunities

EXPERIENCE REQUIRED FOR THE ROLE OF CMC ASSISTANT MANAGER AT ABBOTT 

• Minimum 5 – 10 years of relevant experience in CMC activities
• Knowledge of Global regulatory procedures, CTD guidelines policies and standards
• Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
• Detailed oriented, communication, compliance and process Improvement skills.
• Computer Knowledge: Knowledge of the Office package (Ms Word, Ms Excel, Ms Power Point)

APPLY HERE

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Interview Questions and Answers for the role of CMC Assistant Manager at Abbott 

1. Can you explain your understanding of CMC (Chemistry, Manufacturing, and Controls) in the context of regulatory affairs?

Answer: CMC in regulatory affairs refers to the activities related to the development, manufacturing, and quality control of pharmaceutical products. It involves ensuring compliance with regulatory guidelines and requirements throughout the product lifecycle. This includes preparing CMC documentation for regulatory submissions, managing post-approval changes, and addressing regulatory queries. The CMC Assistant Manager plays a crucial role in coordinating and supporting these activities.

2. How would you approach the task of drafting scientific CMC and regulatory documents for local and regional products?

Answer: When drafting scientific CMC and regulatory documents, I would first ensure a thorough understanding of regional and global regulatory requirements, industry standards, and accepted templates. I would extract relevant scientific information from development reports and organize it in a clear and concise manner. Attention to detail is vital to ensure accuracy and compliance. I would collaborate closely with technical and operational stakeholders to compile and approve the documents, incorporating their input and addressing any issues or concerns.

3. How do you ensure compliance with regulatory procedures and standards in your work?

Answer: Compliance is a critical aspect of my role. To ensure compliance, I stay updated with regulatory legislation and guidelines relevant to the region. I diligently follow Abbott’s internal procedures and quality standards, ensuring that all documents and activities align with statutory and business requirements. Additionally, I maintain accurate records and adhere to the records retention policy. Regular training, self-audits, and collaboration with cross-functional teams also contribute to maintaining compliance throughout the product lifecycle.

4. Can you share an example of a time when you successfully managed conflicting priorities and met deadlines?

Answer: In a previous role, I had to simultaneously manage multiple regulatory submissions with overlapping timelines. To effectively handle this challenge, I prioritized tasks based on urgency, impact, and available resources. I communicated with stakeholders to clarify expectations and negotiate deadlines where necessary. By creating a detailed project plan, delegating responsibilities where appropriate, and effectively managing my time, I successfully met all the required deadlines and ensured that each submission received the attention it deserved.

5. How do you approach process improvement and continuous improvement initiatives?

Answer: I believe in continuously seeking opportunities for process improvement. To start, I actively observe existing processes and identify areas that can be streamlined or made more efficient. I gather feedback from colleagues and stakeholders to understand pain points and areas for improvement. I document these observations and suggestions, and based on them, I propose changes to relevant processes. Additionally, I stay updated with industry best practices and regulatory changes to incorporate them into our existing processes. Regularly reviewing and revising SOPs (Standard Operating Procedures) and providing training to the team are essential components of driving continuous improvement.

ALL THE BEST !