Scientist, Regulatory Affairs-cmc
2 months ago
**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 commercial products.
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Your role at our organization is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.
**Primary responsibilities include, but are not limited to**:
**Regulatory Responsibilities**:
- Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
- Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements/variations, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
- Liaise with global CMC, Our Manufacturing Division and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
- Assess and communicate potential regulatory risks and propose mitigation strategies.
- Deliver all regulatory milestones for assigned products across the product lifecycle
- Identify and communicate potential regulatory issues to GRACS CMC management, as needed
**Technical Skills**:
- Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
- Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
- Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
- Proficient computer skills and previously demonstrated ability to operate in electronic document based GMP systems
**Leadership Skills**:
- Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Capability to handle multiple priorities and balance work to achieve business goals.
- Demonstrated effective leadership, communication, and interpersonal skills
**Qualifications & Skills**
- Bachelor’s in science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
**Who we are **
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
**What we look for **
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to count
-
Assoc. Scientist, Regulatory Affairs-cmc
3 weeks ago
Mumbai, Maharashtra, India MSD Full timeThis 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 commercial products. Our Regulatory...
-
Assoc. Dir., Regulatory Affairs Cmc
6 days ago
Mumbai, India MSD Full time**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...
-
Project Manager, CMC Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full timeAt 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...
-
Project Manager, CMC Regulatory Affairs
3 weeks ago
Mumbai, India 1925 GlaxoSmithKline LLC Full timeAt 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...
-
Project Manager, CMC Regulatory Affairs
2 weeks ago
Mumbai, India 1925 GlaxoSmithKline LLC Full timeAt 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...
-
Project Manager, CMC Regulatory Affairs
3 weeks ago
mumbai, India 1925 GlaxoSmithKline LLC Full timeAt 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...
-
Mumbai, India 1925 GlaxoSmithKline LLC Full timeAs 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...
-
Trainee Cmc
2 weeks ago
Mumbai, Maharashtra, India MSD Full time**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...
-
mumbai, India 1925 GlaxoSmithKline LLC Full timeAs 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...
-
Mumbai, India 1925 GlaxoSmithKline LLC Full timeAs 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...
-
Mumbai, Maharashtra, India Genpact Full timeWith 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...
-
Mumbai, India Genpact Full timeWith 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...
-
mumbai, India Genpact Full timeWith 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...
-
Mumbai, India Genpact Full timeWith 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...
-
mumbai, India Genpact Full timeWith 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...
-
Regulatory Affairs Executive
3 weeks ago
Lower Parel, Mumbai, Maharashtra, India Arch Recruiting solutions Full timeUrgent 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...
-
Regulatory Affairs Officer
4 weeks ago
Lower Parel, Mumbai, Maharashtra, India Arch Recruiting solutions Full timeUrgent 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)...
-
Cmc
2 weeks ago
Mumbai, Maharashtra, India VIPSA TALENT SOLUTIONS PRIVATE LIMITED Full time3 - 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. **...
-
Mumbai, India Abbott Full timeAbbottis a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Abbott...
-
Mumbai, Maharashtra, India Abbott Full timeAbbottis a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Abbott...
