Regulatory Affairs Executive
4 weeks ago
**Job description**
We are looking for a motivated and experienced Regulatory Affairs Specialist to join our team As a Regulatory Affairs Specialist, you will be responsible for the day-to-day monitoring of the company’s regulatory activities to ensure compliance with all regulations. You will be a key member of our regulatory affairs team, which is responsible for the company’s regulatory processes and reporting of the regulatory activities.
Key Requirements
- Update dossiers to mutual recognition standard and progress through national, mutual recognition or decentralised procedures
- Preparation of responses to queries from regulatory agencies on new and existing products in conjunction with relevant personnel.
- Preparation of raw material supplier submissions, review of Active substance master files, CEP review;
- Discussion/Procure and review of audits of existing and new raw material suppliers.
- Preparation and/or updating of product literature in accordance with regulatory and marketing requirements.
- Interaction with partner companies, distributors and provision of the required documentation.
- Clear communication with relevant departments regarding the changes in registered details.
- Provide regulatory compliance information within the company in relation to change control, packaging specification, product literature, and Product Quality Review requirements.
- Filing and retrieval of regulatory information
- Keep abreast of all regulatory legislation and trends in order to provide appropriate guidance / direction to internal and external stakeholders on all areas of regulatory compliance.
- Any other tasks as may be reasonable requested by the Regulatory Affairs Manager.
Other RequirementsEssential
- Minimum of a Bachelor’s Degree in a scientific field such as Biochemistry, Chemistry, Pharmacy or Molecular Biology.
- At least 3-4 years’ Regulatory Affairs experience within the Pharmaceutical or related industry.
- Ability to perform via multitasking.
- Excellent attention to detail.
- Excellent verbal and written communication skills.
- Excellent organisational skills with the ability to prioritise and manage projects within a team environment.
- Good interpersonal skills, building strong working with relationships with stakeholders both internal and external.
- Self-motivated with the initiative and resourcefulness to successfully see projects through to complete
**Job Types**: Full-time, Permanent, Fresher
Pay: ₹15,000.00 - ₹22,000.00 per month
**Benefits**:
- Food provided
- Provident Fund
Schedule:
- Day shift
**Experience**:
- total work: 1 year (preferred)
Work Location: In person
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