Job title: Manager – Regulatory Affairs- Mumbai, India
Company: Novozymes
Job description: Job Ad
Do you want to rethink your impact, and have a good knowledge of Regulatory Affairs, then you might be our new Manager in Regulatory Affairs.
What if you could work for a cause, not just a company?
Novozymes is the global market leader in biological solutions. We help build better lives. Together with our customers, partners and the global community, we use our innovative thinking and passion for science to boost industries and make everyday products more sustainable for the good of the planet. As the world’s leading provider of industrial enzymes and microorganisms, our bio-innovation enables higher agricultural yields, low-temperature washing, energy-efficient production, renewable fuel and many, many other biological solutions that the world can benefit from today and in the future. We call it Rethink Tomorrow.
Join us as our new Regulatory Affairs Manager, Mumbai, India
We are seeking a motivated Candidate who shall be responsible for Domestic and International Registration of Nutraceutical Products. Reporting to the Director of Regulatory Affairs, you will be a key member taking care of Regulatory Department. This role is ideal for a candidate who is independent and highly motivated.
Welcome to Regulatory Affairs
Regulatory Affairs is a position that provides strategic, tactical and operational support to Novozymes core business on regulatory matters that are critical for the development. Novozymes is a high-energy team of 50+ colleagues located over 14 sites in Europe and the Middle East, North and South America, and Asia.
In this role you’ll make an impact by:
- Registration of API, Probiotics and Nutraceutical products with EU (EFSA, ECHA), FSANZ (Australia, New Zealand) and FSSAI India.
- Responsible for preparation of DMF, dossiers of drugs, probiotics and nutraceuticals for regulatory submission.
- Responsible for product life cycle management activities.
- Solely responsible for Technical Data Sheet preparation.
- Experienced in conducting patent searches, landscaping & analysis in order to assess patentability, freedom to operate, patent validity/invalidity in biotechnology domain.
- Trademark & copyright registration- Trademark search, filling application for trademark/ copyright registration, trademark/ copyright objection resolution, trademark protection.
- Coordination with toxicology institutes and CRO’s for range of preclinical and clinical studies for regulatory submissions like EU, US, FSSAI.
- Regulatory and quality compliance in accordance with the national guidelines and liaison with local regulatory authorities.
To succeed you must hold:
- At least ten years of experience in a role relevant to regulatory, product life cycle or document management system, demonstrating:
- strong communication skills
- Well versed with FSSAI, EU (EFSA, Novel Food and ECHA), GRAS, FSANZ (Processing aids), ICH, CTD guidelines
- a desire to work independently and proactively with internal and external stakeholders
- Should possess good knowledge of Dietary Ingredients and Supplements Regulatory Affairs, GRAS file preparation etc.
- A Graduate / Post Graduate in Food Science / Technology.
- Prior experience with specifically a Regulatory Information Management Systems (RIMS), RESTful web services and/or similar Software-aa-a-Service solutions in the field of Regulatory Affairs will be seen as a major advantage.
- Ability to work effortlessly in both written and spoken English, in a global organization with a remote manager.
Location:
This job will be located at Synergia Life Sciences Pvt Ltd (Now a part of Novozymes) Office, Mumbai in India.
Application deadline: 10, October 2022
Novozymes is committed to creating a diverse environment and is proud to be an equal opportunity and affirmative action employer. All employment decisions are based on business needs without regard to race, color, ethnicity, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, disability or veteran status.
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Want to learn more?
At Novozymes, we invite you to join us in finding biological solutions to the world’s problems. Being a pioneering company, we seek people, who are eager to try new things, motivated by challenge and not afraid to fail but driven to try again. And again. Original thinking happens when we’re given the flexibility to focus and the freedom to fully unfold our individual strengths. This is key to our innovation power and how we have become one of the top patent holders in the biotech industry. Learn more about Novozymes, our purpose, and your career opportunities at novozymes.com.
Reference no.
10339BR
Job area
Research and Development
Removal time
midnight Central European Time (CET) / 6pm Eastern Standard Time (EST)
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Expected salary:
Location: Mumbai, Maharashtra
Job date: Thu, 22 Sep 2022 04:42:34 GMT
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