Head - Chief Regulatory Affairs - Pharma

Cheif regulatory affairs

We have urgent requirement for -Regulatory Affairs Head- in Reputed Pharma Company

Position : Regulatory Affairs Head

Qualification : Any graduate/PG

Location : - Surat

Experience : 11 to 18yrs

Job Summary:

The Regulatory Affairs Manager monitors complete product registration lifecycle and ensures compliance with applicable regulations and standard operating procedures.

Supervisory Responsibilities:

- May supervise daily workflow of Regulatory Affairs specialists or other staff.

Duties/ Responsibilities:

- Develops strategies to file the new product registration dossiers, renewal dossiers, query responses, site variations and additional variations as per the planning received from marketing team / management.

- Maintains the track of registration dossiers filed in different countries

- Ensure the timely submissions to comply with government regulations.

- Serves as a liaison between regulatory bodies and operating divisions of the company.

- Prepares and submits applications and reports to applicable regulatory agencies.

- Responds to requests for information from regulatory bodies.

- Coordinates with all relevant sections of manufacturing unit (Production, Quality Control, Quality Assurance) to escalate the document requirement, sample requirement, administrative documents (COPP, GMP, FSC) required for timely submissions.

- Coordinates with all relevant sections of manufacturing unit to process the change controls related to registered products

- Coordinates with the relevant person to legalize, apostil, notarize the administrative documents as per the country requirement

- Co-Ordinate with the marketing and plant for timely dispatch of commercial consignments as per the registered FP specifications

- Should check the artworks of commercial consignments as per the registered artworks

- Monitors regulatory affairs and the effect changes will have on company operations.

Required Skills/Abilities:

- Extensive knowledge of applicable government regulations.

- Ability to inform and educate team members on regulations and polices that require compliance.

- Excellent written and verbal communication skills.

- Excellent analytical and problem-solving skills.

- Excellent strategic planning skills.

- Proficient with Microsoft Office (word, excel, pdf)

Interested candidates kindly contact no-9391466388