Regulatory Affairs - Executive/Assistant Manager/Deputy Manager/Manager Viatris

3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

As an Authoring / writing and reviewing expert, your key responsibilities will include: - Authoring / writing and reviewing CMC sections of dossier - Critically reviewing design stage documents (specifications, controls, and protocols) to ensure regulatory requirements are met - Assessing change controls to determine regulatory impact and strategizing post-approval submissions - Coordinating the collection of post-execution data from various functions and reviewing for compliance with design specifications, controls, and protocols - Collaborating with cross-functional team members to ensure timely resolution of action items identified for responding to deficiencies - Reviewing and ensuring t...

Posted 1 month ago

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Sr Regulatory Consultant (Biologics/Biosimilars) Syneos Health

8.0 - 12.0 years

0 Lacs

pune, maharashtra

On-site

As a Sr Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications. Your responsibilities will include: - Authoring and reviewing CMC sections of regulatory submissions such as INDs, IMPDs, CTAs, BLAs, and MAAs, as well as briefing packages and health authority responses. - Ensuring completeness and compliance of CMC sections within IND and IMPD applications based on regulatory guidance (FDA, EMA, ICH). - Providing peer review and mentorship to junior writers or team members to maintain consistency and scientific accuracy across deliverables. - Staying up...

Posted 1 month ago

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Sr Regulatory Consultant (Biologics/Biosimilars) Syneos Health

8.0 - 12.0 years

0 Lacs

pune, maharashtra

On-site

As a Senior Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications such as INDs, IMPDs, CTAs, BLAs, and MAAs. Your responsibilities will include developing and ensuring the completeness of CMC sections within IND and IMPD applications while adhering to regulatory guidance from FDA, EMA, and ICH. Your expertise in analytical method development, validation, comparability, biosimilarity assessments, upstream and downstream process development will be essential. Furthermore, you will provide peer review and mentorship to junior writers or team members to ...

Posted 3 months ago

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Regulatory Affairs - Executive/Assistant Manager/Deputy Manager/Manager Viatris

3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

As an experienced professional in the pharmaceutical industry, you will be responsible for authoring, writing, and reviewing CMC sections of dossiers. Your critical review skills will be essential in examining design stage documents such as specifications, controls, and protocols to ensure compliance with regulatory requirements. You will play a key role in assessing change controls to determine their regulatory impact and develop strategies for post-approval submissions. Coordinating the collection of post-execution data from different functions and reviewing them against design specifications will be part of your daily tasks. Collaboration with cross-functional team members will be crucial...

Posted 3 months ago

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