Merck Jobs For Lifesciences – CMC Regulatory Specialist
Merck Jobs For Lifesciences – CMC Regulatory Specialist. MSc Life Science candidates apply online for CMC Regulatory Specialist position at Merck. Interested and eligible candidates check all the below:
Job Title: CMC Regulatory Specialist
Job Requisition ID: 212490
Roles responsible for ensuring Organization’s compliance with pharmaceutical regulations and laws as well as providing expertise on drug safety and medical topics.
Includes jobs which are not directly specialized in one of the other defined Regulatory Affairs job families or which are fully responsible for the whole functional area.
IMPACT: Impacts the results of their own team with their own contributions.
COMPLEXITY: Performs routine assignments using existing procedures OR works autonomously within established procedures and practices that require knowledge of concepts and procedures within a job discipline OR specialized technical expertise within an analytical/scientific method or operational process.
ACCOUNTABILITY/ INDEPENDENCE: Accountable for the quality of their own work. Receives instruction, guidance and direction from more senior-level roles.
EXPERIENCE: Typically graduate background with little professional experience. Non-graduate jobholders require a substantial amount of professional experience and additional qualifications that also provides exposure to fundamental theories, principles and concepts.
EXPERIENCE: Typically reports to a manager role, Project Manager role for a defined period of time-based on organizational set-up (there is not necessarily a difference in role level between a manager and its direct reports – same level or lower level reporting is possible, provided job scope and responsibilities are clearly distinct); typically no direct reports.
Provide end-to-end support for Annual Reports and Renewals for all products. Update and review CMC specific documentation, incl. coordination with countries to compile local CMC variations.
Ensure the provision of high-quality CMC dossiers that meet the company’s and health authorities’ requirements. Enable representatives from all major disciplines involved to reach agreement on the CMC dossier and strategy
The position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. The role will support the resolution of complex tasks, under close supervision and guidance provided from the more experienced CMC personnel
Education: Masters in a Life Science or a related discipline.
Work Experience: 5-6 years of overall work experience in a Pharma environment, Competent authority or Academia/R&D experience related to the role. Minimum 3 years of Global CMC regulatory experience
Job-specific Competencies & Skills:
- Management and Planning: Ability to execute assigned tasks with support from team lead/mentor. Adherence to agreed timelines and proactive communication of any potential risk to the same. Provide high-quality deliverables as per Organization standards, “right first time”. Solid knowledge of Organization systems and databases (APT, Trackers, RIMS/Veeva, EDMS). Familiar with the Organization´s organization and ability to identify relevant contributors and stakeholders within the organization as per project. Project management and documentation skills, proactive communication approach. Ability to provide a standard presentation with minimal guidance and support.
- Communication and Collaboration: Excellent written and spoken English language. Demonstrates proficiency in day-to-day business communication. Demonstrates proficiency in compiling and delivering presentations to a target group of people within the own area of specialization/ project environment. Consistently takes an active role in networking activities within own area of specialization/ project environment. Focuses on facts and quality of work rather than the origin of ideas (does not follow cultural stereotypes). Recognizes other’s point of view and makes sure that everyone is listened to and understood. Pursues active networking across disciplines/ areas, projects.
- Systems and Applications: User has advanced skills with all standard MS office and business applications (word, excel, PowerPoint, MS project, outlook, skype, SharePoint). User has a contributor level of experience with RIMS and EDMS RA application. Upon completion of dedicated training, the user can perform routine/ standard activities within the RA systems with no supervision required. The output of the user will usually undergo a standard QC/spot-check procedure.
- Regulatory Expertise: Good knowledge about Regulatory Affairs and specifically post-approval changes, regulatory dossier types and main regulatory procedures globally. Understanding of supportive documents necessary for the registration and LCM of pharmaceutical products (CPPs, GMP Certificates, MLS, AtO’s, AFs, CLs, PoA’s etc.) as well as legalization framework. Ability to review and interpret country-specific and international regulatory guidelines, policies and regulations to generate submission-ready deliverables as per request.
- Pharma business acumen: Have a good understanding of how the business operates and makes smart decisions trying to see the big picture without losing view of the details. Ability to understand and support the life cycle management of regulatory CMC activities Experience in management of regulatory CMC documentation, including variations. Experience with regulatory CMC life-cycle management activities. Practical experience in one of the following areas for biotech or chemical 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.
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