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Clinical Research Manager

2 weeks ago

Anand Petlad Vadodara, India Pharmanza Full time US$ 9,00,000 - US$ 12,00,000 per year

Job Descriptions :

Job Title: Ass. Manager Clinical Research & IPR

Job Location: - Plot No. 214, Borsad - Tarapur Road, Ta: Petlad, Dist: Anand, Gujarat, India. Department: R&D / Regulatory Affairs

Experience: 7 to 10 years in nutraceuticals, clinical research, and IPR.

Industry: Nutraceutical / Food / Pharma Manufacturing

Reports To: Head of R&D / Director

Job Type: Full-Time

Company Profile: -

Pharmanza Herbal Pvt. Ltd. is one of the few companies which is focusing on standardizing and proving the efficacy of Herbal products. Our strong supplier base, fully equipped R&D facility, FDA approved manufacturing facility, infrastructure for conducting human trials as well as our formulations unit provides a one stop solution to our valued customers. Pharmanza Herbal Pvt Ltd. is one of the leading research-oriented companies, manufacturing herbal extracts used in the Ayurvedic and nutraceutical segment. Our journey began in 1997 with Pharmanza India, our group company located in Khambhat, India, where we started producing herbal extracts. While Pharmanza India primarily focuses on veterinary allopathic formulations, we leveraged its facilities to manufacture herbal products such as Garcinia cambogia, Commiphora Mukul, and Withania somnifera from 1997 to 2004. As the business expanded, and we began exporting our products to countries like the US, Japan, and Germany. Pharmanza Herbal was established in Dharmaj, India, to continue our commitment to quality and innovation in herbal solutions. The facility is certified by Food safety authority of India (FSSAI), Food and drug Administration, India (Gujarat office) with NSF-GMP International. Current certifications include ISO9001:2015, ISO22000:2018, NSF-GMP, NSF-SPORT,USP-GMP,USP Ashwagandha,Bosewelia with Kosher and Halal and USDA/APEDA organic certifications for products. Additionally, we are also certified SEDEX 4 Pillers and ECOVADIS.

Job Overview: - Leads clinical research initiatives, ensures regulatory compliance, manages patent filings, and drives innovation. Collaborates with cross-functional teams to develop strategies, analyze data, and protect intellectual property in alignment with organizational and scientific goals.

Responsibilities and Duties: -

  • Clinical Research:
  • Design and execute clinical trials for nutraceutical products (FSSAI-compliant and global standards)
  • Develop study protocols, CRFs, and informed consent documents
  • Coordinate with CROs, ethics committees, and investigators
  • Analyse clinical data for efficacy, safety, and regulatory submissions
  • Prepare Clinical Study Reports (CSRs) and summaries for product dossiers
  • Ensure compliance with ICH-GCP, FSSAI, and international regulatory frameworks
  • Intellectual Property Rights (IPR)
  • Conduct patent landscaping
  • Draft and file patent applications for novel formulations, processes, and delivery systems
  • Monitor competitor IP and identify opportunities for innovation
  • Support trademark filings and brand protection strategies

Qualifications: -

  • Education level: - M.Pharm / M.Sc / Ph.D. in Pharmacology, Life Sciences, Biotechnology, or related field and Certification in Clinical Research / IPR (preferred)
  • Gender: - Any.
  • Salary Range: - Competitive.
  • Skills: -
  • Strong understanding of nutraceutical ingredients, formulations, bioavailability enhancement, and clinical endpoints
  • Familiarity with regulatory pathways (FSSAI, DSHEA, EFSA, FDA)
  • Hands-on experience with clinical trial design and statistical analysis
  • Knowledge of patent databases (Espacenet, WIPO, USPTO) and IP strategy
  • Excellent scientific writing and documentation skills
  • Ability to work cross-functionally with R&D, legal, and marketing teams
  • Benefits:
  • Competitive salary package.
  • Subsidized food facility.
  • Free Transportation facility from Vadodara location.
  • Medi-claim facility.
  • Opportunities for professional development and growth.
  • A dynamic and collaborative work environment committed to sustainability.

Join our team of passionate professionals and contribute to the growth and success of our nutraceutical product portfolio. If you have the required expertise and are ready to take on this exciting challenge, we encourage you to apply now.

Company Website: - Company Email id: -