DSM Nutritional Products Job – Life Science Regulatory Affairs Manager
DSM Nutritional Products Job – Life Science Regulatory Affairs Manager. Life Sciences Regulatory Affairs Manager Job Opening. Interested and eligible applicants can check out all of the details on the same below:
Job ID: 35922
Job function: Quality, SHE & Security
Experience level: Experienced Hire
Business: DSM Nutritional Products
Name of the Post: Regulatory Affairs Manager, South Asia
We are seeking a Regular Affairs Manager for South Asia, based in Mumbai or New Dehli. The incumbents’ role is to add to the Regulatory and Product safety compliance of DSM products and/ or raw materials.
The incumbent will:
- Responsible/assist in the product approval and upkeep of compliance in the South Asian markets for Human Nutrition and Health.
- Responsible/assist in providing advice/recommends to Marketing and Sales, Product Management, DSCM, Purchasing in all regulatory as well as quality-related topics/issues of straights.
- Responsible/assist in providing support of marketing as well as sales in customer contacts to RA and QM/ QC related topics including alignment of customer quality agreements.
The Challenge:
- Registration of products with DCGI in India & DGDA in Bangladesh & foodstuff approval from FSSAI in India.
- Proactively support as well as advise different South Asia internal stakeholders (e.g. R&D, Sales, Marketing, Manufacturing, SHE, logistics, purchasing etc.) with respect to regulatory requirements, custom clearance, product regulatory quality; compliance; and/or product safety for DSM products and/or raw materials
- Proactively support (with standard product documents and/or non-standard statements) and also advise South Asia external stakeholders– food & pharma products customers.
- Review relevant Regulatory and/or Product Safety legislation related to product compliance and also provide input on implementation and also status (e.g. regarding pharma, food approval). Notify internal stakeholders regarding changes in South Asia pharma & food regulations.
- Support as well as maintain relevant internal systems and also databases for guaranteeing regulatory (quality) and/or product safety compliance for raw materials and also products
- Build a pharma & food regulatory network– regulatory authority, industry association in India
- Projects/special assignments
- Bulk Drug registration/renewal in India
- Prep Work of Source Validation registration dossiers for submission in Bangladesh
The Ideal:
- University degree in natural/life sciences or related disciplines
- Knowledge on regulations as well as standards for DNP (DSM Nutritional Products) and DFS (DSM Food Specialties) business
- Experience in handling regulations for Food sciences (with a favorable choice on those additionally handling or have actually handled Pharma).
- Experience and/or abilities in advocacy with India based stakeholders.
- Great language abilities (English, the local language where necessary, others appreciated).
- People management experience (this position would certainly have one report).
- Team working abilities.
- Certified background in preparing a technical dossier for regulatory submission.
- Quality management experience a plus.
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