Deputy Manager, Regulatory Affairs

RXinsider LTD.; Gujarat; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Amneal is seeking an experienced Regulatory Affairs professional to lead strategies for complex products including injectables and 505(b)(2) filings for US and EU markets. The role requires driving cross-functional collaboration to ensure timely and compliant submissions.

You will draft and finalize Pre-ANDA/Pre-IND packages, prepare deficiency responses, and mentor team members on evolving regulatory requirements. A strong track record in regulatory strategy and quality mindset is essential.

Qualifications

• Strong scientific and regulatory background.
• Pharmacy degree with regulatory/pharmaceutics focus.
• 12+ years experience in regulatory affairs for injectable dosage forms.
• End-to-end understanding of complex products for US/EU filing and deficiency responses.

Responsibilities

• Prepare, review and finalize regulatory strategies for complex products and 505(b)(2) filings.
• Draft and finalize Pre-ANDA/Pre-IND and ScA meeting packages.
• Draft controlled correspondences and deficiency responses.
• Review API and finished product in vitro characterization reports.
• Collaborate with cross-functional teams and meet timelines and quality.
• Provide training on new regulatory requirements for complex products.

Skills

Regulatory strategy

Cross-functional collaboration

Quality mindset

Problem solving

Documentation drafting

Education

Pharmacy degree (M.Pharm or PhD)

Regulatory Affairs specialization

12+ years regulatory experience

Job description

Job Description

• Prepare, Review and Finalize Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market.
• Draft, Review and Finalize Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market.
• Draft and finalize controlled correspondences on complex issues.
• Draft, Review and Finalize 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.
• To collaborate and work closely with cross functional teams.
• To meet the management expectations w.r.t timelines and quality.
• To work closely within the team and provide training to new members on new regulatory requirements for Complex products.

Qualifications

• Suitably qualified individuals with strong Scientific and Regulatory background.
• Academic degree in Pharmacy (M. Pharm or PhD), with preferably specialization in Regulatory Affairs or Pharmaceutics.
• Experienced (minimum 8-10 years) in Regulatory Affairs with Injectable dosage form and overall experience 12+ years.
• End to end complete understanding of Complex Products for US/ EU market right from Strategy, Filing, Deficiency response etc.
• Experienced in drafting controlled correspondences, Meeting packages etc.
• Experience being an active contributor to cross-functional teams and/or working in matrix organizations. High quality, critical thinking, process, and performance orientated; prioritizes activities and projects.
• Exercises good judgment on regulatory, quality, and technical related compliance issues. High personal integrity; trustworthy; strong compliance and quality mind-set.
• Solution orientated, 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.