Regulatory Affairs Assistant Manager Hiring | Alembic Pharmaceuticals

Alembic Pharmaceuticals is hiring an Assistant Manager for Regulatory Affairs at its Vadodara location. This role is ideal for individuals with extensive experience in regulatory processes, compliance with FDA standards, and managing export product registrations.

Key Responsibilities:

As a Regulatory Affairs Assistant Manager, you will play a crucial role in ensuring the company’s products meet all regulatory standards. Your responsibilities include:

• Person who has been working in Regulatory Affairs for the last 10-15 years and are eager to continue growing Person who has career in this field.
• Person who has knowledge of labelling requirements as per the D&C ACT.
• Person who is well-versed with applicable Regulatory guidance, D&C Rules, including NDCT-2019.
• Person who has possess technical knowledge and understanding of licensing requirements for the Indian and  ROW markets.
• Person who has experience in handling Artwork related activities in coordination with CQA & PDC.
• Person who is skilled in Liaisoning with State Food and Drug Administration for necessary Licensing/Regulatory work.
• Person who has excel in preparing and reviewing applications for Manufacturing Site/Product Licenses and FDA Correspondences.
• Person who is capable of handling Regulatory Queries, including #NSQ and Market Complaints.
• Person who has experience with Export Product Registration.
• Person who is proactive in staying updated on recent circulars/communications from Regulatory Authorities for execution and compliance.
• Person who can assess products for updated pharmacopoeia compliance.
• Person who is proficient in dealing with FDA/Outside Testing Labs and coordinating with relevant departments to meet the requirements received from FDA labs.
  • Person who can manage control samples with FDA sample portions as per D&C rules.
  • Person who has completed Bachelor’s in Pharmacy or Master’s in Chemistry and possess strong communication skills.
  • Person who enjoy working in a friendly environment.
  • Person who is eager to guide and mentor younger team members and are willing to take initiative.
  • Person who is self-motivated and do not require constant supervision to get the job done.
  • Person who is proactive, able to apply critical thinking to solve problems, eager to learn new skills, and can take ownership of outcomes.This role is not suitable for freshers or individuals without these specific skills. If you do not meet these criteria, please explore other suitable opportunities at Alembic Pharmaceuticals.

Required Qualifications and Skills:

To be considered for this role, candidates must possess:

• A B.Pharm or M.Sc. in Chemistry or a related field.
• 10-15 years of experience in Regulatory Affairs, particularly in the pharmaceutical industry.
• Strong knowledge of D&C Act, NDCT 2019, and regulatory guidelines for the Indian and ROW markets.
• Hands-on experience liaising with FDA and managing product licenses.
• Expertise in HPLC/GC instruments is an added advantage.
• Excellent communication and project management skills.

Location:

Vadodara, Gujarat, India

How to Apply:

If you meet the qualifications and are excited to join a leading pharmaceutical company, submit your CV to vivek.amishra@alembic.co.in. Include your Notice Period, Current CTC, and Expected CTC.