CMC/RA Subject Matter Expert

Job description

People empowerment is essential to the growth of the company. This role requires an expert in CMC/RA, who has an excellent track record of experience and expertise, who is looking to expand their career further with challenges of a diversified portfolio of clients and products.

Key Responsibilities

  • Subject Matter Expert for the CMC/RA domain
  • Provide strategic inputs to projects and business discussion relating to CMC/RA Thorough understanding of ICH/EU/US guidelines relating to CMC/RA
  • Review and approve CMC/RA related documentation
  • Hands-on approach to ensure the successful completion of the project
  • Participate in business development activities such as attending Client’s TC / meetings
  • Maintain updated knowledge on new guideline / legislation related to the CMC/RA domain
  • Identify new business opportunities within the CMC/RA domain

Offer:

An opportunity to enhance your experience/expertise within the pharmaceutical industry from small to large companies with a varying degree of therapeutic areas and pharmaceutical forms.

Ideal Candidate:

  • Well verse with EU/US & RoW requirements and guidelines
  • Experience working with EU/US competent authorities
  • Work experience in any of the EU5 agencies would be an asset
  • Core expertise in CMC

About ELC:

ELC Group is a global life science partner within the pharmaceutical industry. From formulation development through to the implementation of clinical trials, registration, commercialization, safety & life cycle maintenance, ELC aligns itself as a strategic partner to help pharmaceutical companies achieve their healthcare goals.

As a small mid-sized company, we prioritise on the growth of the business while ensuring the development of our team. We believe that when the people grow, the company grows and vice versa. Every individual in the company is given

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