Am - Drug & Regulatory Affairs (Pharmaceutical

7 days ago


Chandigarh, India Maya Biotech PVT LTD Full time

Dossier preparation, compilation and review.
- Preparing of STS,STP,COA,STABILITY DATA.
- Knowledge of CTD & ACTD Studying scientific and legal documents
- gathering, evaluating, organising, managing and collating information in a variety of formats
- ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA)
- maintaining familiarity with company product ranges
- planning, undertaking and overseeing product trials and regulatory inspections
- keeping up to date with changes in regulatory legislation and guidelines
- analysing complicated information, including trial data
- offering advice about company policies, practices and systems
- providing advice about regulations to manufacturers/scientists
- ensuring that quality standards are met and submissions meet strict deadlines
- preparing documentation.
- ensure that a company's products comply with the regulations of the regions where they want to distribute them
- keep up to date with national and international legislation, guidelines and customer practices
- collate and evaluate scientific data from a range of sources
- develop and write clear explanations for new product licences and licence renewals
- undertake and manage regulatory inspections
- review company practices and provide advice on changes to systems
- liaise with, and make presentations to, regulatory authorities
- undertake and manage regulatory inspections

Schedule:

- Day shift
- Morning shift

Ability to commute/relocate:

- Industrial Area, Chandigarh - 160002, Chandigarh: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 9 years (preferred)
- Drug & regulatory affairs: 5 years (preferred)

**Speak with the employer**

+91-XXXXXXXXXX



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