MSD Biopharmaceuticals Hiring For Manager, Regulatory Affairs CMC

latest pharmaceutical job at MSD – Hiring Manager. MSD Biopharmaceuticals, a leading global pharmaceutical company, is currently seeking a highly skilled and experienced professional to join their team as a Manager, Regulatory Affairs CMC. Interested & eligible candidates. can check the details below and apply online.

Job title: Manager, Regulatory Affairs CMC

Job Location: Mumbai, Maharashtra, India

Job id: R247249

Education Level: Bachelor’s / Graduation / Equivalent

Job Category: Full Time

about company 

They are a research-driven biopharmaceutical company. their mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

They are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, they have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment

of diseases that threaten people and animals around the world.

Job Description for latest pharmaceutical job at MSD

Manager, Regulatory Affairs CMC

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.

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 required for latest pharmaceutical job at MSD

• 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 

Possible interview questions that could be asked for latest pharmaceutical job at MSD 

1. Question: Can you describe your experience in developing and implementing CMC regulatory strategies for pharmaceutical products?

Answer: In my previous role, I was responsible for developing and implementing CMC regulatory strategies for various pharmaceutical products. I ensured compliance with global regulations and guidelines while assessing CMC changes, identifying regulatory requirements, and evaluating supporting documentation. I have successfully prepared and reviewed regulatory CMC dossiers for commercial products, including post-approval supplements, variations, annual reports, and registration renewals.

2. Question: How do you handle potential regulatory risks and propose mitigation strategies?

Answer: When assessing potential regulatory risks, I carefully analyze the situation, identify the key risks, and evaluate their potential impact. I then collaborate with cross-functional teams, such as global CMC, Manufacturing Division, and external partners, to develop effective mitigation strategies. By maintaining open communication channels, staying updated on regulatory changes, and proactively addressing potential issues, I ensure compliance and minimize risks throughout the product lifecycle.

3. Question: Can you explain your experience in working with electronic document-based GMP systems?

Answer: Throughout my career, I have gained proficiency in using electronic document-based GMP systems. I have successfully operated such systems to manage and maintain regulatory documentation, ensuring accuracy, traceability, and compliance. My experience includes authoring, reviewing, and tracking documents related to CMC submissions, post-approval changes, and other regulatory requirements. I understand the importance of maintaining data integrity and the secure exchange of information within these systems.

4. Question: How do you approach communication with key stakeholders in the regulatory process?

Answer: Effective communication is crucial in regulatory affairs. I believe in building strong relationships with key stakeholders by actively listening to their concerns, understanding their perspectives, and providing clear and concise information. I ensure that I communicate regulatory issues and updates in a succinct and logical manner, tailoring the message to the audience’s level of understanding. By fostering open dialogue and collaboration, I facilitate smooth regulatory processes and align everyone towards achieving business goals.

5. Question: Can you give an example of a challenging situation you faced in regulatory affairs and how you resolved it?

Answer: In a previous project, we encountered unexpected changes in the regulatory landscape that affected the approval process for a key product. To address this challenge, I proactively engaged with regulatory agencies to gain a deeper understanding of the updated requirements. I collaborated with cross-functional teams to assess the impact on our CMC strategy and developed an action plan to address the gaps. By effectively communicating the changes internally and implementing necessary adjustments, we successfully navigated the regulatory hurdles and achieved timely approval for the product.

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