Shri Kartikeya Pharma - Manager / Senior Manager - Global Regulatory Affairs
SHRI KARTIKEYA PHARMAHyderabad, India2 days ago
Job descriptionDevelop and implement regulatory strategies for product launches and market expansions. Ensure the certifications are renewed on time and also apply for new certifications in new geographies. Interpret and apply country-specific regulations (FDA / DSHEA, EFSA, FSSAI, etc.) to ensure compliance. Prepare and maintain regulatory submissions, including product dossiers, GRAS documentation, and ingredient justifications. Ensure technical files and records (safety data, clinical support for claims, specifications) are Claims & Marketing Review : Review and approve labels, packaging, and marketing materials for regulatory compliance. Evaluate substantiation for health and structure / function claims to ensure legal Collaboration : Collaborate with R&D, Quality, Marketing, and Legal teams to align product development with regulatory requirements. Provide regulatory support during product lifecycle management and Liaison : Act as the point of contact with national and international regulatory agencies (e.g., FDA, EFSA, FSSAI, TGA). Lead the response to agency inquiries, inspections, or compliance reviews Provide internal training on new regulations and compliance procedures. Identify and mitigate regulatory risks associated with ingredients, claims, or Qualifications : Bachelor's or Masters degree in Pharmacy, Food Science, Chemistry, Life Sciences, or a related discipline. 5+ years of experience in regulatory affairs in the nutraceutical, dietary supplement, or functional foods sector. Strong knowledge of international regulatory frameworks : FDA / DSHEA (U.S.), EFSA (EU), FSSAI (India). Familiarity with Codex Alimentarius and GMP guidelines preferred. Excellent written and verbal communication skills. Attention to detail and experience handling complex Experience : 10-12 Years of experience from a Pharma / Nutraceutical Industry Experience with digital regulatory platforms or document management systems. Experience interacting directly with regulatory authorities or participating in audits / inspections. Regulatory submissions for new ingredients, import / export regulatory support.
Manager / Senior Manager - Global Regulatory Affairs (10-12 the Company :
Shri Kartikeya Pharma is one of Indias leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts.
Title : Manager / Senior Manager- Global Regulatory 8-12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements, Herbal Extracts, Functional Foods, or Pharma (with strong exposure to nutraceutical regulations).
- Strong background in compiling and reviewing Technical Dossiers :
- Ingredient dossiers
- Regulatory compliance documents
- Safety and toxicology data
- Stability data
- Label claim As per the Market Shri Kartikeya Pharma, 3rd Floor, PBN Centre, Road No : 45, Jubilee Hills, of the Role :
The Global Regulatory Affairs Manager will oversee all regulatory compliance activities related to the companys nutraceutical products, ensuring that all the marketing practices meet applicable global standards (e.g., FDA (U.S.), EFSA (EU), FSSAI Strategy & Compliance :
Dossier & Documentation Management :
Training & Risk Management :
(ref : iimjobs.com)
Create a job alert for this search
Manager • Hyderabad, India
Related jobs
- Promoted
Asst Manager- Regulatory Affairs
ConfidentialHyderabad / Secunderabad, Telangana, India Prepare, compile, and submit regulatory dossiers and submission data.Manage Test and Manufacturing License applications with state and central drug authorities.
Handle regulatory submissions, variat...Show moreLast updated: 22 days ago
- Promoted
- New!
Regulatory Affairs Manager
Ixoreal BiomedHyderabad, IN Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts.Title : Manager / Sen...Show moreLast updated: 3 hours ago
- Promoted
Head of Pharmacy
Confidential CompanyHyderabad, Telangana, India Job Summary : The Head of Pharmacy will be responsible for overseeing and managing the entire pharmacy department within the hospital, ensuring the safe, effective, and efficient use of medications...Show moreLast updated: 2 days ago
- Promoted
Regulatory Affairs Senior Manager (CMC)
ConfidentialHyderabad / Secunderabad, Telangana, India The RA CMC Senior Manager is responsible for execution and / or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful exec...Show moreLast updated: 12 days ago
- Promoted
Shri Kartikeya Pharma - Senior Manager / Manager - Business Development & Sales
SHRI KARTIKEYA PHARMAHyderabad, India Company : Shri Kartikeya Pharma is one of Indias leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplemen...Show moreLast updated: 2 days ago
- Promoted
Regulatory reporting - Senior Manager
ConfidentialHyderabad / Secunderabad, Telangana, India We are looking for a result driven individual to manage the Regulatory Reporting team responsible for assessing regulatory reporting requirements, identifying SSGM change as a result of those requi...Show moreLast updated: 22 days ago
- Promoted
Research Director
MNR UniversitySangareddi, Telangana, India Research Director Job Description Overview : The Director of Research is a senior academic leadership role within a department.
The role supports the strategic development of the department’s researc...Show moreLast updated: 7 days ago
- Promoted
Global Regulatory Manager-Mumbai / Hyderabad
ConfidentialHyderabad / Secunderabad, Telangana, India Directs the development of submission of product registration, progress reports, supplements, amendments, and / or periodic experience reports.
Provides strategic product direction to teams on interac...Show moreLast updated: 22 days ago
- Promoted
Senior Regulatory Affairs Specialist
ConfidentialHyderabad / Secunderabad, Telangana, India Dyaz Innovate is a software company with its flagship product, DyazRIMS™, which supports the entire regulatory compliance process.
The company is committed to enhancing regulatory processes for clie...Show moreLast updated: 22 days ago
- Promoted
Regulatory Affairs Specialist – (APAC & RoW)
vueverse.Hyderabad, IN Regulatory Submissions & Compliance.Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, ...Show moreLast updated: 17 days ago
- Promoted
Manager / Sr Manager -Pharmacy
Continental HospitalsHyderabad, Telangana, India Continental Hospital is a JCI and NABH accredited facility offering multi-specialty, tertiary, and quaternary care services.
With 585 beds and more than 50 specialties, the healthcare institution is...Show moreLast updated: 4 days ago
- Promoted
Senior Manager -Advanced Battery Chemistry
Amara Raja Advanced Cell TechnologiesHyderabad, Telangana, India The Amara Raja Group is one of India’s leading and fastest-growing conglomerates, with a revenue exceeding USD 2 billion and a global presence across multiple industries.
Backed by a diverse team of...Show moreLast updated: 18 days ago
- Promoted
Azurity Pharmaceuticals - Senior Manager - IPR
Azurity PharmaceuticalsHyderabad, India About the job : Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the need...Show moreLast updated: 30+ days ago
- Promoted
Manager, Regulatory Affairs
ConfidentialHyderabad / Secunderabad, Telangana, India Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients.
As an industry leader in providing uniq...Show moreLast updated: 20 days ago
- Promoted
Regulatory Affairs Manager (CMC)
ConfidentialHyderabad / Secunderabad, Telangana, India The RA CMC Manager is responsible for execution and / or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution a...Show moreLast updated: 12 days ago
- Promoted
Deputy General Manager
MSN LaboratoriesPatancheru, Telangana, India MSN Labs is the fastest growing research-based pharmaceutical company based out of India.Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has 17 API and...Show moreLast updated: 8 days ago
- Promoted
Shri Kartikeya Pharma - Senior Manager / Manager - Marketing
SHRI KARTIKEYA PHARMAHyderabad, India Company : Shri Kartikeya Pharma is one of Indias leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredien...Show moreLast updated: 2 days ago
- Promoted
Director of Physical Therapy
MNR UniversitySangareddi, Telangana, India Physical Director Job Description Physical Director's job includes managing physical education programs, organizing sports events, ensuring student participation, and overseeing staff.Key responsib...Show moreLast updated: 7 days ago