8 BDHRS Talent 4.0 Jobs
Manager - Regulatory Affairs - Agrochemicals (6-13 yrs)
BDHRS Talent 4.0
posted 9d ago
Key skills for the job
Manager - Regulatory affairs (Agrochemicals)
Job Title: Manager Regulatory Affairs (Agrochemicals)
Reporting To: Business Head - Agrochemicals
Job Location: Pune, India
About the role:
- In this role, you will be working with regulatory/compliance authorities, local distributors (or company partners) and different departments within global and local company ensuring our products meet all regulatory/compliance requirements.
- You will be responsible for ensuring that our products comply with all regulations and guidelines set by regulatory agencies.
- This role involves preparing and submitting regulatory documents, brands & patents, maintaining regulatory files, and staying updated on changes in regulations.
- This position requires a deep understanding of agricultural regulations and the ability to manage multiple projects simultaneously.
What you will deliver:
- Prepare files, liaise with partners, submit to the authority, track, archive and manage label update submissions across Middle East and Africa with exposure in Sub Saharan African countries & Maghrib regions
- Liaise with local marketing and market access divisions to provide regulatory support.
- Prepare and manage new product submissions for regulatory approval to the local authority
- Collaborate closely with the International Marketing team to ensure the submission of dossiers & timely approvals
- Work in coordination with R&D, Quality Assurance, and the Formulation team to gather and compile necessary data for dossiers
- Coordinate the dispatch of regulatory samples to international clients as needed
- Maintain, track and update data for international registration statuses and reporting
- Data collection and analysis in collaboration with Contract Research Organizations (CROs)
- Co-ordination with GLP (Good laboratory practices) laboratories, Universities, Consultants and internal departments to provide registration support to clients
- Closely Working with CIB (Commercial Item Descriptions) /FCO (fertilizer control order) for the Registration Process of Agrochemicals and Fertilizers
- Attend regular compliance committee meetings both internal & external and keep track of compliance topics
- Develop and maintain good relationship with key internal & external stakeholders with continuous interaction to meet business challenges
- Develop regulatory strategies and implementation plans for the preparation and submission of new products
Education & skills required:
- Bachelor's or Master's Degree in Agriculture
- Professional experience with 6+ years of relevant/ global regulatory affairs experience in the Agri based industry for Africa & Asia
- Good communication skills, attention to detail, execute with accuracy & sense of urgency
- Ability to work across different nationalities, geographies & time zones
- Good knowledge of African registration requirements between CILSS / OAPI/ ARIPO/ COMESA
- Stay abreast of the knowledge of current and evolving regulatory procedures and changes
- Knowledge of 3rd party regulatory agency requirements and communication protocols & handling defined regulatory matters
Functional Areas: Pharma/Healthcare
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