Manager/Sr. Manager Regulatory Affairs– Emerging Markets
3 weeks ago
UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was founded in 1983 and has business operations in more than 85 countries including EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries.We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement.As part of our further expansion and growth plans, we are looking to hire Manager / Sr Manager Regulatory Affairs– Emerging Markets in Regulatory Affairs department.This position is based at our R&D center at Turbhe Navi Mumbai and will report to the Head Regulatory Affairs.The remuneration package will be commensurate with the incumbent’s professional experience and will be in line with market standards.Role & responsibilities:Regulatory Strategy & Planning: Develop and implement strategic plans for regulatory submissions and ongoing compliance. Submission Management: Oversee the preparation and submission of regulatory applications and amendments to relevant agencies. Agency/Customer Interaction: Serve as a primary point of contact with customer/regulatory authorities, representing the company. Lifecycle Management: Manage the regulatory lifecycle of approved products, including handling post-approval changes, supplements, and annual renewals. Documentation & Reporting: Critically review and approve all regulatory documents for accuracy, completeness, and adherence to regulatory standards. Audits & Inspections: Coordinate and support company activities during regulatory agency audits and inspections. Team Leadership & Collaboration: Guide and mentor junior staff, manage multiple projects simultaneously, and collaborate with internal cross-functional teams and external counsel. Required Skills & Qualifications:Education: Bachelor’s or master’s degree in pharmacy (B. Pharm, M. Pharm). Experience: 13-15 years of experience in regulatory affairs, with emerging market experience Technical Expertise: Deep understanding of CMC documentation (Chemistry, Manufacturing, and Controls) and the product development process. Communication: Excellent written and verbal communication skills for internal coordination and external agency interactions. Problem-Solving: A solution-oriented mindset with a capability for risk assessment and mitigation.
-
Navi Mumbai, Maharashtra, India, Maharashtra Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
-
Navi Mumbai, Maharashtra, India Umedica Laboratories Private Limited Full time ₹ 12,00,000 - ₹ 36,00,000 per yearUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
-
Regulatory affairs manager
3 weeks ago
Mumbai, Maharashtra, India, Maharashtra SOZIO Full timeCompany :Founded in 1758 in Grasse in the south of France, Maison Sozio is one of the pioneers in fine French perfumery.The history of the Maison Sozio goes back to one of the very first families of perfumers in Grasse, having been at the origin of the community of glove-makers and perfumers.With the integration of Synarome in 2021, Sozio ties back to its...
-
Regulatory affairs manager
4 days ago
Mumbai, Maharashtra, India SOZIO Full time ₹ 1,20,000 - ₹ 1,80,000 per yearCompany :Founded in 1758 in Grasse in the south of France, Maison Sozio is one of the pioneers in fine French perfumery.The history of the Maison Sozio goes back to one of the very first families of perfumers in Grasse, having been at the origin of the community of glove-makers and perfumers.With the integration of Synarome in 2021, Sozio ties back to its...
-
Regulatory Affairs-CMC
2 weeks ago
Navi Mumbai, Maharashtra, India Peoplefy Infosolutions Full time ₹ 9,00,000 - ₹ 12,00,000 per yearWe're Hiring: Regulatory Affairs CMC Associate Location: Navi Mumbai Years of Experience:4+ years Work from Office Notice Period: Looking for immediate joiners Skills Required: Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field. 4+ years of experience in Regulatory Affairs (CMC), preferably in a pharmaceutical or...
-
Regulatory Affairs Associate
2 weeks ago
Navi Mumbai, Maharashtra, India Peoplefy Full time ₹ 9,00,000 - ₹ 12,00,000 per yearWe're Hiring: Regulatory Affairs – CMC Associate Location: Navi Mumbai Years of Experience:4+ years Work from Office Notice Period: Looking for immediate joiners Skills Required: Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field. 4+ years of experience in Regulatory Affairs (CMC), preferably in a pharmaceutical or...
-
Manager Regulatory Affairs
5 days ago
Navi Mumbai, Maharashtra, India Bharat Serums and Vaccines Full time ₹ 20,00,000 - ₹ 25,00,000 per yearRole & responsibilitiesPreparation and reviewing of CTD and ACTD dossier.Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission.Co-ordination with plant for Regulatory compliances.Timely achievement of monthly plan & timely query response.Gap Analysis/Updation of Master data.Review of Change Controls, Stability Protocol,...
-
Manager - PLCM (Regulatory Affairs)
2 weeks ago
Mumbai, Maharashtra, India Apotex Full timeAbout Apotex Inc.Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the...
-
Vice President Regulatory Affairs
7 days ago
Mumbai, Maharashtra, India Utkarsh Placement Pvt. Ltd. Full time ₹ 20,00,000 - ₹ 25,00,000 per yearOne of our esteemed Pharma client based at Mumbai is looking for AVP/VP Regulatory Affairs for US Markets. Job Description is given below;Job Description – Vice President (VP) Regulatory AffairsIndustry:Pharmaceutical ManufacturingLocation: MumbaiExperience:20+ yearsQualification:BPharm/M.Pharm / Ph.D. in Pharmaceutical SciencesRole OverviewWe are seeking...
-
Associate, Regulatory Affairs
4 days ago
Mumbai, Maharashtra, India Colgate-Palmolive Full time ₹ 5,00,000 - ₹ 15,00,000 per yearRelocation Assistance Offered Within Country Mumbai, Maharashtra, IndiaWho We AreColgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries and territories...
