Senior Manager, Regulatory Affairs CMC - Hyderabad

Job Description · Senior Manager, Regulatory Affairs CMC · This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance's and defined regulatory strategies. He would even be responsible fo ...

This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance's and defined regulatory strategies. · ...

This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance's and defined regulatory strategies. · Provide input to global product and project regulatory strategies by performing assessme ...

Preparation, review and compilation of assigned ANDA/NDA [505 b (2)]/projects for filing and knowledge of eCTD, Module 2 and 3. Hands on experience in reviewing CMC documents of Solid and Liquid Oral Dosage forms. · Preparation, review and compilation of Supplements and Amendment ...

Extensive experience in managing and developing strategies for new registrations life cycle maintenance and renewals for biological products including vaccines recombinant proteins monoclonal antibodies and plasmaderived therapies across major markets such as the US EU Japan Cana ...

When our values align, there's no limit to what we can achieve. · At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something ...

10+ years of experience in handling of new registration, life cycle management, renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules in various markets, mainly in US, EU, Japan, Canada Switzerland, Australia. ...

The Associate Director, Regulatory Affairs (CMC) will provide strategic and operational leadership for Chemistry, Manufacturing, and Controls (CMC) regulatory activities across multiple product modalities including biologics, small molecules, and combination products. · ...

Responsible for CMC regulatory matters relating to registrations and/or life-cycle maintenance of business activities (including variations and renewals) for assigned product portfolio. · ...

Regulatory Affairs Manager facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. · ...

Experienced regulatory affairs professional with expertise in ANDA,NDA submissions, eCTD, CMC review, IP strategy and team management. · ...

At Demo SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Senior Associate to join our team. The job responsibilities for this position includes post-marketing regulatory submissions for Europe a ...

At Demo SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented · Regulatory Affairs Senior Associate · to join our team. The job responsibilities for this position includes post-marketing regulatory submissions for · Eu ...

At Demo SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Associate to join our team. The job responsibilities for this position includes post-marketing regulatory submissions for Europe and othe ...

At Demo SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented · Regulatory Affairs Associate · to join our team. The job responsibilities for this position includes post-marketing regulatory submissions for Europe and ...

At Demo SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Associate to join our team. The job responsibilities for this position includes post-marketing regulatory submissions for Europe and othe ...

At Demo SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Senior Associate to join our team. The job responsibilities for this position includes post-marketing regulatory submissions for Europe a ...

The Associate Director is a senior people leader responsible for the operational effectiveness, · staff engagement and strategic alignment of Amgen's CMC & Device Regulatory Team in Amgen India (AIN). · Key responsibilities include providing inclusive leadership for staff within ...

The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, · as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. · ...

We are hiring for two critical positions with a leading pharmaceutical organization. · ...