Manager - Regulatory Affairs - Agrochemicals

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