Responsibilities:

- Authoring regulatory submissions: Writing and reviewing the CMC sections for new e.g. New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs) and lifecycle maintenance regulatory filings including responses to Health Authority’s questions.

- Ensuring regulatory compliance: Making sure that all documents align with the requirements of regulatory bodies as well as International Council for Harmonisation (ICH) guidelines.

- Collaborating with subject matter experts (SMEs): Working closely with scientists, quality assurance (QA), manufacturing teams, and regulatory affairs colleagues to gather accurate and complete information about a drug's composition, manufacturing process, and quality control.

- Maintaining document quality: Ensuring completion of high-quality documents i.e. clear, concise, scientifically accurate, and consistent in style and format, complying with regulatory guidelines and internal processes within timelines.

- Managing timelines: Adhering to strict project schedules to ensure timely completion of submissions.

- Identify, Assess and Communicate potential CMC Regulatory issues and propose mitigation strategies.

- Understands, interprets and guides teams on regulations and policies related to manufacture and control of medicinal products to expedite the submission, review and obtain approvals.





Essential skills and qualifications

- Educational background: A bachelor's degree or higher in a scientific field, such as Chemistry, Pharmaceutical Sciences, or a related discipline.

- Experience: Minimum of 5 ~ 9 years of relevant work experience working within a Regulatory Affairs Department with direct accountability for deliverables.

- Pharmaceutical experience: Prior experience authoring CMC sections for regulatory submissions is a standard requirement.

- Technical writing expertise: Exceptional technical writing, editing, and communication skills are required to translate complex scientific data into clear regulatory documentation.

- Regulatory knowledge: A solid knowledge of CMC regulatory requirements for multiple global regions (e.g., APAC, U.S., EU) is essential. Experience with the electronic Common Technical Document (eCTD) format is also crucial.

- Industry familiarity: A background in pharmaceutical manufacturing or quality control is often beneficial.

- Collaboration and project management: The ability to work independently, manage projects, and communicate effectively with cross-functional teams is critical.

- Detail-oriented: Meticulous attention to detail is necessary to ensure the accuracy and completeness of submissions.

📌 Senior Associate/Strategist Regulatory Affairs (APAC CMC) (Bengaluru)
🏢 Important Company of the Sector
📍 Bengaluru