Assoc. Scientist, Regulatory Affairs-cmc

**Scientist 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 for the preparation and review of information required for development of regulatory CMC dossiers for...

**Associate Director, Regulatory Affairs CMC** The Associate Director is responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidance’s, and our company's procedures. Would also lead the preparation and submission of CMC dossiers for life-cycle changes to...

**Trainee CMC** The Trainee - Regulatory Affairs will be a part of the GRACS team which supports regional CMC strategy, preparation of CMC documentation. Under the direction of the area supervisor, responsible for the planning, preparation, and release of regulatory submissions (IND/CTA, NDA/BLA/MAA, post-approval supplements, annual reports, etc.) and...

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...

As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously. You will interpret and advise teams on global guidelines, procedures and...

As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously. You will interpret and advise teams on global guidelines, procedures and...

As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously. You will interpret and advise teams on global guidelines, procedures and...

3 - 6 years' work experience in CMC documents review and in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines. **Experience in Formulations Analytical Development, Formulations Development or Pharmaceutical product development activities and eCTD submissions will be an added advantage. **...

Urgent Requirement Location - Lower Parel, Mumbai Designation - Regulatory Affairs - Executive Experience - 2yrs - 6yrs Qualification - B Pharma Must have Key Skills: CTD/ ACTD/ CMC/ technical review/ Dossier/ MOH queries/ Variations/ Renewals. Other essential skills: Regulated markets Job description: Common requirements: 1) Complete understanding of...

Urgent Requirement Location - Lower Parel, Mumbai Designation - Regulatory Affairs Officer Experience - 3yrs - 10yrs CTC - 3lacs to 10lacs Qualification - B Pharma Must have Key Skills: CTD/ ACTD/ CMC/ technical review/ Dossier/ MOH queries/ Variations/ Renewals. Other essential skills: Regulated markets Job description: Common requirements: 1)...

With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world's biggest brands—and we have fun doing it We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We're harnessing the power of technology and humanity to create...

With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it! We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We’re harnessing the power of technology and humanity to create...

With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it! We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We’re harnessing the power of technology and humanity to create...

With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it! We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We’re harnessing the power of technology and humanity to create...

With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it! We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We’re harnessing the power of technology and humanity to create...

1) Complete understanding of requirements & regulations of ASEAN/ AFRICA/LATAM/ GCC/ MENA markets wrt New submissions, Re-registration & Variations. 2) Prior experience of carrying out high quality CMC review of all kind of technical documentation & Art-works, 3) Review and /or Compilation of country specific/ CTD/ACTD dossiers for new submissions &...

We Requires 2 **Regulatory Affairs Executive** for **Pharma **Company at **Goregaon**: - West **Designation**:Regulatory Affairs Executive** Experience : 1 to 3 Years **Education**:B Pharm / M Pharm **[**Compalsary **] Salary : up to 30K Location**:Goregaon**: - **West** **Responsibilities**: - Preparing and submitting the relevant regulatory...