MSD Regulatory Affairs Job For BSc Biology, Microbio, Virology, Mol Bio & Biochem, Apply Online
MSD Regulatory Affairs Job For BSc Biology, Microbio, Virology, Mol Bio & Biochem, Apply Online. MSD BSc Biology, Microbiology, Virology, Molecular Biology, or Biochemistry job opening. Interested and eligible applicants can check out all of the details on the same below
If you are wondering what kind of interview questions can be asked for the role of Manager, Regulatory Affairs CMC at MSD, then check out some of the possible interview questions below along with the answers.
Post Name – Manager, Regulatory Affairs CMC
Location – Mumbai, Maharashtra, India
Job ID: R247249
Job Description
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.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.
We are a research-driven biopharmaceutical company. Our 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.
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Who we are …
We 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, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our 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.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
If you are wondering what kind of interview questions can be asked for the role of Manager, Regulatory Affairs CMC, then check out some of the possible interview questions below along with the answers.
- Can you explain the role of regulatory affairs in implementing CMC regulatory strategies for pharmaceutical products? How do you ensure compliance with global regulations and guidelines?
Answer: Regulatory affairs plays a crucial role in developing and implementing CMC regulatory strategies for pharmaceutical products. It involves assessing CMC changes, identifying regulatory requirements, and evaluating supporting documentation. Compliance is ensured by adhering to established business processes, liaising with global CMC and external partners, and mitigating potential regulatory risks.
- How do you approach the preparation and review of regulatory CMC dossiers for commercial products? What are the key components and documentation involved?
Answer: When preparing and reviewing regulatory CMC dossiers, I meticulously analyze scientific information, ensuring technical merits and clear presentation of data-driven conclusions. Key components include post-approval supplements/variations, annual reports, registration renewals, and responses to health authority questions. It is essential to present information in a succinct and logical manner, leveraging strong oral and written communication skills.
- How do you assess potential regulatory risks and propose mitigation strategies? Can you provide an example where you successfully handled a regulatory issue?
Answer: Assessing regulatory risks involves identifying potential challenges and proposing effective mitigation strategies. For instance, if a change in manufacturing processes may impact product quality, I would thoroughly evaluate the implications and propose necessary adjustments to ensure regulatory compliance. Through proactive communication and collaboration with stakeholders, I strive to address regulatory issues promptly and implement suitable solutions.
- How do you stay updated with industry advancements and evolving regulatory requirements? Can you give an example of how you applied this knowledge to enhance regulatory strategies?
Answer: I actively stay abreast of industry advancements and evolving regulatory requirements through continuous learning and engagement with relevant resources. For example, attending regulatory conferences, workshops, and reviewing publications and guidelines enable me to gather insights. By integrating this knowledge, I enhance regulatory strategies, ensuring they align with the latest standards and best practices.
- Can you share an experience where you demonstrated effective leadership and communication skills in a regulatory affairs context? How did you handle multiple priorities and achieve business goals?
Answer: As a regulatory affairs professional, I have successfully demonstrated effective leadership and communication skills by fostering collaboration with cross-functional teams. For instance, in a project involving multiple regulatory submissions, I prioritized tasks based on business goals, coordinated efforts, and ensured efficient execution. Regular communication, setting clear expectations, and adapting to changing priorities were key in achieving successful outcomes while maintaining compliance.
Remember, these sample answers can serve as guidelines. It’s important to personalize your responses based on your experience and achievements in the field of regulatory affairs.
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