Regulatory Affairs Jobs at Astellas | Chemistry Candidates Apply
Are you looking for Regulatory Affairs Jobs with a global pharmaceutical leader? Astellas Careers offers an exciting opportunity for a Regulatory Affairs Specialist – CMC Small Molecules in Bengaluru. This role is ideal for professionals seeking growth in Astellas Jobs, working on innovative drug development while contributing to global regulatory submissions in a dynamic and collaborative environment.
About Astellas
Astellas is a global pharmaceutical company dedicated to turning innovative science into VALUE for patients. Through its strong focus on research, quality, and regulatory excellence, Astellas Careers offers professionals the opportunity to work on impactful therapies while growing within a globally respected organization. With expanding Global Capability Centers, Astellas Jobs provide exposure to international regulatory standards, cutting-edge science, and long-term career development.
Title: Regulatory Affairs Specialist – CMC Small Molecules
Astellas’ Global Capability Centers – Overview
Astellas’ Global Capability Centers (GCCs) are strategically located sites that enable Astellas to access talent across various functions in the value chain and co-locate core capabilities that are currently dispersed. Our three GCCs are in India, Poland, and Mexico.
The GCCs will enhance our operational efficiency, resilience, and innovation potential, enabling a timely response to changing
business demands.Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turning innovative science into VALUE for patients.
This position is based in Bengaluru and will require some on-site work.
Purpose and Scope:
The Specialist, CMC Regulatory Affairs Jobs (RA), is responsible for supporting CMC regulatory activities for our company’s products in accordance with global regulations and guidelines, and is responsible for technical content input and coordination of CMC submissions for all assigned activities. Product responsibilities, including supporting biologics programs, could be in the development or the marketed product phase of a drug product lifecycle.
Responsibilities and Accountabilities:
- Contribute to the preparation, compilation, and transmittal of CMC submissions according to the defined schedules and meet both Health Authority and Astellas established SOPs/guidance.
- Contribute to the regulatory impact assessment of proposed CMC changes and monitor the progress of the CMC changes with regulatory impact.
- Ensure proper CMC document, including version control and metadata, and dossier management.
- Support the CMC RA colleagues on assigned products and be accountable for the delivery of all assigned regulatory activities, including IND/CTA, original BLA/MAA, agency background packages, post-approval submissions/variations, and responses to health authority questions per established business processes and systems.
- Identify, communicate, and escalate potential issues to the CMC RA Scientific Lead.
- Act as CMC RA Deputy to support CMC RA Scientific Lead for both development programs and commercial products for regulator filing.
- Contribute to collecting, interpreting, archiving, and knowledge sharing of regulatory requirements for both BLA/MAA and post-approval submissions.
- Develop an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval, product launch, and maintenance of market supply of our company’s human medicinal products worldwide.
- Conduct all activities with an unwavering focus on compliance, including staying current on all training.
- Carry out all assignments to the standards of efficiency, innovation, accuracy, and safety in accordance with company and regulatory requirements.
- Additional activities may be assigned by the supervisor.
Quantitative Dimensions:
- Position will interact with individuals outside of CMC Regulatory Affairs, such as Global Regulatory Affairs, Quality Assurance and Product Development, and Manufacturing.
- Position will provide support to multiple projects, some with overlapping timelines.
- Position should be able to apply scientific knowledge to assigned projects, and use working knowledge of relevant regulations and guidelines to assist in the success of projects and programs.
Organizational Context:
- Reports to Director or Senior Director, Regulatory Affairs CMC.
- Position can provide support to the entire CMC Regulatory Affairs department through cross-modalities team collaborations.
Required Qualifications:
- Bachelor’s (minimum) or graduate degree (preferred) in chemistry, biology, engineering, or a related field. Fields of study include Chemistry, Pharmacy, Chemical Engineering, Biology, Microbiology, Biochemistry, or other similar scientific disciplines.
- At least three (3) years of relevant experience in regulatory CMC, or biological or vaccine research, manufacturing, testing, or related fields for candidates with a bachelor’s degree or 1 year with a graduate degree.
- The ideal candidate must have the ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and whether conclusions are adequately supported by data.
- The ideal candidate must have strong organizational skills with the ability to combine information from different systems.
- The candidate must be proficient in English; additional language skills are a plus.
Preferred Qualifications:
- Experience in small molecules is preferred.
- Experience in operating CMC regulatory and/or QA/GMP related database, such as Veeva Vault, TrackWise Digital, etc.
- Knowledge of FDA/EMA, ICH regulations and guidelines (and beyond), and the ability to provide interpretations of that information to others.
