Exciting Career Opportunity in Alvotech: Regulatory Manager CMC Job- Apply Now
Alvotech, a global leader in biopharmaceuticals, is seeking a Manager, Regulatory CMC in India. This role offers a unique opportunity to work on cutting-edge biologics, ensuring compliance with EMA, FDA, and WHO regulatory guidelines. If you have expertise in Regulatory CMC and a passion for advancing healthcare, this could be your next career move. Join a fast-growing, innovative company
that values diversity, collaboration, and work-life balance. Apply now!Position: Manager, Regulatory CMC
Location: India
Employment Type: Full-time
Application Deadline: April 16, 2025
Scope & Responsibilities:
- Obtain and manage CMC-related documents for regulatory submissions.
- Ensure compliance with ICH, FDA, EMA, WHO, and other regulatory guidelines.
- Collaborate with internal teams and CMOs to prepare high-quality regulatory sections.
- Lead responses to CMC-related questions from regulatory authorities.
- Establish strategies for document authoring and quality.
- Implement industry standards for regulatory submissions.
- Communicate unified regulatory messages at interdisciplinary meetings.
- Identify and mitigate regulatory CMC risks.
- Promote continuous improvement within regulatory compliance.
- Ensure an efficient and transparent working environment within GRA.
- Perform other tasks as required by senior management.
Job Requirements for Alvotech Regulatory Manager CMC Job
- Bachelor’s or master’s degree in biotechnology, Life Sciences.
- 5+ years direct industry experience in Regulatory CMC Biologics, 10+ years industry-relevant experience.
- Hands-on experience with EMA/FDA/PMDA/Health Canada CTD requirements.
- Proven ability to produce high-quality CMC documentation for complex large molecules.
- Knowledge of CMC expectations at all stages of product development.
- Experience with post-market activities in the LCM space preferred.
- Strong communication and interpersonal skills.
- Ability to work independently and prioritize tasks effectively.
- Proficiency in English, written and spoken.
What we offer:
- An inspiring challenge to work with great co-workers on ambitious projects that change people’s lives.
- The chance to be part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration, and inclusion.
- Positive, flexible, and innovative work environment.
- A clear and developed organizational structure.
- Training and global opportunities to advance.
- A good work-life balance.
- Home internet and home office equipment.
Why Alvotech:
At Alvotech, we are committed to delivering affordable biologic medicines and creating a healthier world. Our values of integrity, gender equality, and fairness guide everything we do. Join us in fostering an inclusive and diverse working environment where you can grow your career and make a meaningful impact.
Keywords: Alvotech, Manager, Regulatory CMC, biotechnology, Life Sciences, EMA, FDA, CTD requirements, communication skills, global company, work-life balance
