Deputy Manager, Regulatory Affairs

Amneal Pharmaceuticals; Gujarat; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Amneal Pharmaceuticals in Gujarat, India is looking for an experienced individual in Regulatory Affairs to prepare and review regulatory strategies for complex products like injectables for the US and EU markets. Candidates should have a strong scientific background, preferably with an M. Pharm or PhD, and must possess a minimum of 12 years of experience, including at least 8-10 years in Regulatory Affairs with injectable dosage forms.

The role requires a solution-oriented mindset and a collaborative approach since it involves working closely with cross-functional teams and training new members on regulatory requirements.

Qualifications

• Minimum 8–10 years of experience in Regulatory Affairs with injectable dosage forms.
• End-to-end comprehensive understanding of complex products for the US/EU market.
• Experience in drafting controlled correspondences and meeting packages.

Responsibilities

• Prepare, review and finalise regulatory strategies for complex products.
• Draft and finalise deficiency responses for complex products.
• Collaborate with cross-functional teams and provide training.

Skills

Strong scientific and regulatory background

Critical thinking

Collaboration and teamwork

Solution-oriented approach

Education

M. Pharm or PhD in Pharmacy

Job description

Job Description

• Prepare, Review and Finalise Regulatory strategies for Complex Products (like injectables that may include Peptides, Microspheres, Liposomes, Nano‑suspensions, Ophthalmic, Otic, Topical gel, DDCP, etc.) and 505(b)(2) Products for the US and EU market.
• Draft, Review and Finalise Pre-ANDA/Pre‑IND/ScA meeting packages for the US and EU market.
• Draft and finalize controlled correspondences on complex issues.
• Draft, Review and Finalise Deficiency responses for Complex Products and 505(b)(2) Products.
• Review API and FP in‑vitro characterization/sameness reports.
• DMF review for complex APIs as per the workflow.
• Collaborate and work closely with cross‑functional teams.
• Meet management expectations with respect to timelines and quality.
• Work closely within the team and provide training to new members on new regulatory requirements for Complex products.

Qualifications

• Suitable individuals with strong scientific and regulatory background.
• Academic degree in Pharmacy (M. Pharm or PhD), preferably with specialization in Regulatory Affairs or Pharmaceutics.
• Minimum 8–10 years of experience in Regulatory Affairs with injectable dosage forms and overall experience of 12+ years.
• End‑to‑end comprehensive understanding of complex products for the US/EU market, from strategy to filing to deficiency response.
• Experience in drafting controlled correspondences, meeting packages, etc.
• Active contributor to cross‑functional teams and experience working in matrix organisations. High quality, critical thinking, process‑ and performance‑oriented; prioritises activities and projects.
• Good judgement on regulatory, quality, and technical compliance issues. High personal integrity; trustworthy; strong compliance and quality mindset.
• Solution‑oriented, strong sense of ownership and accountability.
• Collaborative, team‑oriented approach, capable of working cross‑functionally, and in a matrixed and integrated way.

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.