Associate Regulatory at Merck, Interested and eligible candidates check out all the details given for the same below.
Job Position: Associate
Job Location- Electronic City Phase 1- Bangalore
Job Requisition ID: 267650
Career Level: C – Professional (1-3 years)
The Associate Regulatory Affairs CMC (RA-CMC) is responsible for and contributes to driving assigned CMC regulatory activities including planning CMC Dossier generation for assigned submissions worldwide.
Job Description for Associate Regulatory at Merck:
Role is responsible for ensuring companies compliance with pharmaceutical regulations and laws as well as providing expertise on drug safety and medical topics.
IMPACT: Impacts the results of own team or even influences a range of customer, operational, project or service activities of closely related teams with own contributions. Explains complex or even difficult/sensitive information to others in straightforward situations and interacts across business areas. May even advance discussions and build consensus across the business and with external parties regarding own technical area.
COMPLEXITY: Performs a range of routine or even non-routine assignments to solve problems of low to moderate complexity that require working knowledge and experience in own job discipline. Analyzes factual information and possible solutions to make independent judgement, recommendations and decisions. May alsouse best practices to improve products or services.
ACCOUNTABILITY/ INDEPENDENCE: Accountable for the quality of own work. Works independently and receives a moderate to low level of guidance and direction within clear or even broad guidelines.
Requires a graduate background plus some to substantial relevant professional experience, and good knowledge and experience in own discipline and beyond. Minimum 1 -3 years of pharmaceutical industry experience
Education for Associate Regulatory at Merck:
Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline
Job Specific Competencies & Skills:
- Ability to understand and support the development of regulatory CMC strategies and CMC dossiers i.e. Module 3, Module 2
- Comprehensive knowledge and Experience with developing regulatory CMC strategies and CMC dossier content requirements i.e. Module 3, Module 2.
- Experience in preparation and management of regulatory CMC documentation, including preferably international new product applications or variations
- Experience with regulatory CMC life-cycle management activities would be an asset
- Practical experience in one of the following area synthetic molecules and/or biotech molecules: manufacturing process development, transfers, validation or analytical development and quality management
- Awareness of global pharmaceutical legislation specifically linked to regulatory CMC aspects in the ICH countries.
- Excellent written and spoken communication skills in English (knowledge of other European languages is an asset such as German).
- Good interpersonal skills and flexible mindset.
- Attention to details.
- Ability to work in multinational teams.
- Awareness of Project management
- Awareness of regulatory CMC affairs contribution to Pharma business
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Possible interview questions may be asked for Associate Regulatory at Merck
- Can you explain your understanding of the role of an Associate Regulatory Affairs CMC and its importance in the pharmaceutical industry? Answer: “An Associate Regulatory Affairs CMC plays a crucial role in ensuring a pharmaceutical company’s compliance with regulatory requirements related to Chemistry, Manufacturing, and Controls (CMC) of drug products. This role involves planning and contributing to the generation of CMC dossiers for submissions worldwide. It’s essential because it ensures that our products meet quality, safety, and efficacy standards, allowing them to be available to patients while complying with regulations set by health authorities.”
- What specific experiences and skills do you possess that make you a strong candidate for this role?Answer: “I have a solid educational background with a Master’s degree in a Life Science discipline, which provides me with a strong foundation in the scientific aspects relevant to this role. I also have 2 years of experience in the pharmaceutical industry, where I’ve been involved in regulatory CMC documentation preparation and management. My expertise includes developing CMC strategies, understanding Module 3 and Module 2 requirements, and managing international product applications. Additionally, I have practical experience in manufacturing process development, validation, and quality management for synthetic molecules.”
- Can you provide an example of a challenging regulatory issue you’ve encountered in your previous role, and how did you resolve it? Answer: “In my previous role, we faced a challenging regulatory issue related to a change in the manufacturing process for one of our products. It required a thorough understanding of the existing regulatory CMC documentation and the impact of the change. I worked closely with cross-functional teams to compile the necessary data, conducted risk assessments, and developed a comprehensive regulatory strategy. By effectively communicating with regulatory authorities and providing a well-documented submission, we successfully obtained approval for the process change without any delays in production.”
- How do you stay updated on changes in pharmaceutical regulations, especially in international markets?Answer: “Staying updated on regulatory changes is vital in this role. I make it a point to regularly review guidelines and updates from regulatory agencies such as the FDA, EMA, and ICH. I also actively participate in industry conferences, webinars, and seminars to network with experts and gain insights into evolving regulations. Additionally, I am a member of professional organizations related to regulatory affairs, which provides access to valuable resources and discussions on regulatory updates.”
- Can you describe a situation where you had to work in a diverse, multinational team? How did you ensure effective collaboration and communication? Answer: “In my previous role, I was part of a multinational team responsible for a global product submission. Effective communication was crucial due to the team’s diverse backgrounds and locations. I ensured collaboration by establishing clear communication channels, scheduling regular virtual meetings to accommodate different time zones, and using collaboration tools like Slack and Microsoft Teams. I also encouraged open and respectful communication, ensuring that every team member’s perspective was valued. This approach led to a cohesive and productive team that successfully achieved our submission goals.”
Editor’s Note: Merck Hiring- Associate Regulatory CMC for Life Science Candidates Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.
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