West-Coast Pharmaceutical Works Ltd. has announced a job opportunity for the position of Regulatory Affairs Officer at its Sola, Ahmedabad, Gujarat location. The company is looking for experienced candidates with 2 to 5 years of relevant experience in pharmaceutical or nutraceutical regulatory affairs.

Candidates with knowledge of regulatory submissions, product registration, pharmaceutical documentation, and GMP and QC documentation can apply for this opportunity. Immediate joiners will be preferred.

Job Details

• Company Name: West-Coast Pharmaceutical Works Ltd.
• Post Name: Regulatory Affairs Officer
• Department: Regulatory Affairs
• Experience Required: 2 to 5 years
• Job Location: Sola, Ahmedabad, Gujarat
• Working Hours: 9:00 AM to 7:00 PM
• Working Days: Monday to Saturday
• Joining Preference: Immediate joiners preferred
• Job Type: Full-time

Educational Qualification

Candidates should have a relevant educational background in pharmacy or a related pharmaceutical field. A B.Pharm, M.Pharm, or another relevant qualification may be suitable, depending on the company’s requirements. Applicants should confirm the exact qualification criteria with the HR department before applying.

Job Responsibilities

The selected candidate will be responsible for the following activities:

1. Research regulatory requirements for pharmaceutical and nutraceutical product registration in different countries.
2. Prepare and submit regulatory applications, reports, and supporting documents to the appropriate regulatory authorities.
3. Respond to requests for information and clarification from regulatory bodies.
4. Prepare product registration dossiers according to applicable international regulatory requirements.
5. Conduct technical reviews of pharmaceutical data, reports, and regulatory documents.
6. Prepare and review Good Manufacturing Practice (GMP) documents, including FDR, MFR, MPR, BPR, BMR, pharmacovigilance (PV) protocols, and reports.
7. Prepare and review Quality Control (QC) documents, including raw material specifications (RM SPEC), packaging material specifications (PM SPEC), finished goods specifications (FG SPEC), Certificates of Analysis (COA), and Methods of Analysis (MOA).
8. Stay updated on current regulatory guidelines and requirements applicable to pharmaceutical and nutraceutical products.

Required Skills

Candidates should have a sound understanding of pharmaceutical regulatory affairs, product registration procedures, and technical documentation. Knowledge of GMP, quality control documentation, dossier preparation, and regulatory submission requirements will be beneficial.

Good communication skills, attention to detail, document review capabilities, and the ability to coordinate regulatory submissions are also important for this position.

How to Apply

Interested and eligible candidates can send their updated CV to the HR email address provided below.

• HR Email: hrdho@westcoastin.com
• HR Contact Number: +91 98751 70543

Applicants should mention “Application for Regulatory Affairs Officer” in the email subject line and include their relevant work experience and current contact details.

Immediate joiners are preferred. Candidates are advised to verify the job details and eligibility criteria with the company’s HR department before applying.

Frequently Asked Questions (FAQs)

1. What is the role of a Regulatory Affairs Officer in the pharmaceutical industry?

A Regulatory Affairs Officer ensures that pharmaceutical and nutraceutical products comply with applicable regulatory requirements. The role includes product registration, dossier preparation, regulatory submissions, document review, and communication with regulatory authorities.

2. What experience is required for this position?

West-Coast Pharmaceutical Works Ltd. is seeking candidates with 2 to 5 years of relevant experience in regulatory affairs or related pharmaceutical documentation activities.

3. What are the important technical documents handled in this role?

The responsibilities include reviewing GMP documents such as MFR, MPR, BPR, and BMR, along with QC documents such as raw material specifications, packaging material specifications, finished goods specifications, COA, and MOA. FDR and PV protocols and reports are also mentioned in the recruitment notice.

4. What is a pharmaceutical regulatory dossier?

A regulatory dossier is a structured collection of technical and administrative documents submitted to regulatory authorities to support product registration or approval. Depending on the applicable regulatory framework, it may include information about product quality, manufacturing processes, specifications, analytical methods, stability studies, and supporting safety or efficacy data.

5. What is the job location and how can candidates apply?

The position is based in Sola, Ahmedabad, Gujarat. Interested candidates can email their updated CV to hrdho@westcoastin.com or contact HR at +91 98751 70543. Immediate joiners are preferred.