Operation Executive

5 days ago

Baddi, India Maya Biotech PVT LTD Full time

**As an RA Officer, your job description may include the following**:

- submitting adjustments to registration dossiers to the MEB and supervising the registration procedure to obtain and maintain registration through interaction with national and international health authorities and the headquarter-relevant departments in case of concerns;
- assessing and, if necessary, advising on adapting the chemical-pharmaceutical part of registration dossiers and, in collaboration with Medical Affairs, preparing corresponding letters with arguments to the MEB, international Health Authorities and the Head Quarters (HQ);
- ensuring compliance with the risk management plan (RMP), the accompanying educational materials and ensuring timely MEB assessment of related educational materials;
- contributing to various product strategic plans regarding timing, opportunities and threats relating to regulatory matters of both your company’s own and competitive products, including regulatory advocacy;
- checking that leaflets and packaging material comply with the quality of the pharmaceutical company and the legislator;
- assessing the medical scientific correctness and conformity with the SmPC of promotional material, in relation to the Medicines Act and the Code of Conduct for Pharmaceutical Advertising;
- maintaining contacts and sharing relevant information with relevant disciplines, internally and externally, nationally and internationally (marketing, medical, clinical, headquarters, R&D, health authorities and external experts).

**Job Types**: Full-time, Permanent

Pay: ₹9,668.85 - ₹26,645.37 per month

Schedule:

- Morning shift

**Experience**:

- total work: 10 years (required)

Ability to Commute:

- Baddi, Himachal Pradesh (required)

Ability to Relocate:

- Baddi, Himachal Pradesh: Relocate before starting work (required)

Work Location: In person

**Speak with the employer**
+91 7696499825

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