MSD Scientist Job For BSc – Apply Online
MSD Scientist Job For BSc – Apply Online. MSD Scientist Job For BSc in Biology, Microbiology, Virology, Molecular Biology, or Biochemistry. Interested Candidates check out the details below and Apply Online
Job title: Scientist, Regulatory Affairs-CMC
Job Location: Pune & Mumbai, Maharashtra, India
Job iD: R253036
Job Category: Full Time
Job Description
Scientist 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.
MSD Scientist Job For BSc. Here are five Possible interview questions along with answers:
1. Question: Can you elaborate on your experience in managing CMC regulatory submissions for pharmaceutical products and how it aligns with the responsibilities outlined in the job description? Answer: I have over 5 years of experience in the pharmaceutical industry, with 4 years dedicated to managing CMC regulatory submissions for a range of products, including small molecules, vaccines, and biologics. During this time, I have successfully executed regulatory strategies by authoring and reviewing CMC submission components, addressing post-approval supplements, annual reports, and responses to health authority inquiries. My experience in liaising with cross-functional teams and external partners has equipped me with the ability to ensure compliant change management and maintain regulatory conformance.
2. Question: Could you provide an example of a challenging situation you faced while preparing CMC regulatory documentation, and how did you handle it? Answer: Certainly. In a previous role, we encountered a situation where unexpected changes in manufacturing processes required rapid adjustments to the CMC submission for a vaccine. I promptly organized a cross-functional team to assess the impact, gather necessary data, and revise the submission within a tight timeline. I ensured clear communication with all stakeholders, managed priorities effectively, and coordinated with external partners to achieve regulatory compliance without compromising quality.
3. Question: The job description emphasizes the importance of assessing potential regulatory risks. How do you approach identifying and mitigating these risks in your regulatory strategies? Answer: Identifying regulatory risks involves a thorough assessment of potential challenges that could impact the submission process. I analyze the scientific rationale and technical data to evaluate if they align with global regulatory requirements. In cases where risks are identified, I propose mitigation strategies by collaborating with cross-functional teams and providing feasible solutions. This approach ensures that the regulatory strategy is proactive and minimizes the chances of delays or rejections.
4. Question: Can you discuss your experience in collaborating with global CMC, manufacturing, and external partners to support change management? Answer: Collaboration is essential in regulatory affairs. I have worked closely with global CMC teams, manufacturing divisions, and external partners to facilitate compliant execution of change management processes. I ensure that all stakeholders are aligned on regulatory requirements and that changes are implemented smoothly while adhering to established processes. Clear communication and coordination play a pivotal role in achieving successful change implementation.
5. Question: The job description mentions the need for innovative problem-solving and effective leadership skills. Could you provide an example of how you demonstrated these skills in a complex regulatory scenario? Answer: In a complex regulatory scenario, we faced unexpected delays in the approval of a critical post-approval supplement. I took the lead in identifying the root cause, gathered input from relevant departments, and proposed an innovative solution to expedite the approval process. I collaborated closely with the regulatory authorities, presenting a well-structured case supported by data. Ultimately, our approach not only resolved the issue but also established a precedent for efficient problem-solving within the team.
Remember, these are sample answers, and you should tailor your responses to your actual experiences and accomplishments.
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