Merck BSc Regulatory Affairs Job – Biochem, Biology, Mol Bio & Microbiology Apply

Merck BSc Regulatory Affairs Job – Biochem, Biology, Mol Bio & Microbiology Apply

Merck BSc Regulatory Affairs Job – Biochem, Biology, Mol Bio & Microbiology Apply. Merck & Co is Hiring BSc Biology, Microbiology, Virology, Molecular Biology, or Biochemistry for Regulatory Affairs. Interested Candidates can check out the details below and Apply Online.

Job title: Manager, Regulatory Affairs CMC

Job Location: Mumbai, Maharashtra, India

Job ID: R256770

Job Category: Regulatory Affairs CMC

Job Type: Full Time

Job Description

This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance’s and defined regulatory strategies. He would even be responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Your role at our organization is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness

to help make meaningful contributions to global medical advancement.

Primary responsibilities include, but are not limited to:

Regulatory Responsibilities:

• Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
• Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements/variations, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
• Liaise with global CMC, Our Manufacturing Division and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
• Assess and communicate potential regulatory risks and propose mitigation strategies.
• Deliver all regulatory milestones for assigned products across the product lifecycle
• Identify and communicate potential regulatory issues to GRACS CMC management, as needed

Technical Skills:

• Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
• Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
• Proficient computer skills and previously demonstrated ability to operate in electronic document based GMP systems

Leadership Skills:

• Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Capability to handle multiple priorities and balance work to achieve business goals.
• Demonstrated effective leadership, communication, and interpersonal skills

Qualifications & Skills

• Bachelor’s in science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry
• Minimum 5 – 7 yrs of Industry Pharmaceutical industry experience out of 4 years’ experience in managing CMC Regulatory submissions for small molecules/vaccines/biologics. The candidate may be required to travel to other CMO sites on a need basis.

APPLY ONLINE 

Merck & Co is Hiring BSc Biology, Microbiology, Virology, Molecular Biology, or Biochemistry for Regulatory Affairs. Here are five Possible interview questions along with their corresponding answers:

Question 1: Can you describe your experience in developing and implementing CMC regulatory strategies for pharmaceutical products? Answer: Certainly. In my previous role, I was responsible for developing and executing CMC regulatory strategies for a range of pharmaceutical products. I conducted assessments of CMC changes, identified global regulatory requirements, and reviewed supporting documentation to ensure compliance with regulations. This involved collaborating with cross-functional teams, including global CMC, Manufacturing, and external partners, to ensure the seamless execution of change management. My experience allowed me to identify potential risks and propose mitigation strategies, ensuring regulatory conformance throughout the product lifecycle.

Question 2: How do you ensure effective communication with cross-functional teams and external partners in the context of regulatory affairs? Answer: Effective communication is crucial in regulatory affairs. I have strong oral and written communication skills, which enable me to clearly convey complex regulatory information and issues to various stakeholders. I actively engage with cross-functional teams to discuss regulatory milestones, potential risks, and mitigation strategies. By maintaining open lines of communication, I ensure that all team members are aligned with regulatory goals and requirements. My experience has shown that transparent communication fosters collaboration and helps achieve business objectives.

Question 3: Can you provide an example of a challenging regulatory issue you’ve faced and how you successfully addressed it? Answer: Certainly. In a previous project, we encountered a complex CMC change that required swift regulatory action due to manufacturing process modifications. I had to assess the technical merits of the changes, evaluate potential risks, and develop a comprehensive regulatory strategy. I collaborated closely with manufacturing and quality assurance teams to gather data and evidence supporting the change. By effectively communicating the rationale behind the modifications, addressing potential concerns preemptively, and providing a well-structured submission, we successfully obtained regulatory approval with minimal delays.

Question 4: How do you stay updated on evolving global regulations and guidelines in the pharmaceutical industry? Answer: Staying current with global regulations is crucial in regulatory affairs. I regularly participate in industry conferences, webinars, and workshops focused on regulatory updates. Additionally, I am an active member of regulatory networks and forums where professionals share insights and interpretations of new guidelines. I also subscribe to regulatory authority notifications and publications to ensure that I am aware of any changes that could impact our products. This proactive approach enables me to incorporate the latest regulatory requirements into our strategies.

Question 5: Describe a situation where you had to lead a cross-functional team to achieve a critical regulatory milestone. How did you approach this and what was the outcome? Answer: In a recent project, our team needed to prepare a comprehensive regulatory submission for a post-approval variation. I took the lead in coordinating efforts among the CMC, Manufacturing, and Quality teams. I ensured that each team understood their roles and responsibilities, established clear timelines, and maintained open lines of communication. By leveraging my leadership and communication skills, we successfully compiled the necessary documentation, addressed health authority questions, and obtained regulatory approval within the anticipated timeline. This experience highlighted the importance of collaboration and effective leadership in achieving regulatory milestones.

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