Assistant Manager / Sr. Executive

Nivagen Pharma (india); Ahmedabad District; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Nivagen Pharma (INDIA) Pvt. Ltd. located in Ahmedabad, INDIA, seeks an Asst. Manager/Sr. Executive for the Regulatory Affairs Department to lead and coordinate regulatory submissions for PIND, IND, NDA and ANDA, including USFDA-related activities.

The role requires a strong background in sterile injectable and solid oral dosage forms, with hands-on eCTD proficiency and cross-functional teamwork across R&D, QA and manufacturing. Excellent communication skills are essential.

Qualifications

• M.Pharm./M.Sc./Ph.D. with 5–10 years pharma industry experience and USFDA working exposure.
• Strong analytical skills and business acumen for generics product launches.
• Ability to network across functions and integrate cross-functional deliverables.
• Sterile injectable and solid oral dosage form registration experience required.
• Proficiency in eCTD, SPL, MS Office, and MS Project.
• Strong oral and written communication skills.

Responsibilities

• Develops and implements submission strategies for PIND, 505(b)(2); NDAs; ANDA.
• Leads planning, writing and review of regulatory submissions for PIND/IND/NDA/ANDA.
• Reviews documentation from clinical development, QA, R&D, and other departments.
• Ensures project timelines are set and delays communicated with rationale.
• Interprets regulations and provides regulatory leadership to project teams.

Skills

Regulatory submissions

USFDA experience

Cross-functional collab

Communication skills

Education

M.Pharm./M.Sc./Ph.D.

Tools

eCTD software

SPL

MS Office

MS Project

Job description

Job description for Asst. Manager/Sr. Executive - Regulatory Affairs Department

(USA market)

Location: Nivagen Pharma (INDIA) Pvt. Ltd., Satellite, Ahmedabad, INDIA

Report to: Manager, Regulatory Affairs, Nivagen Pharmaceuticals

Job Description

• 1. Develops and implements submission strategies for PIND, 505(b)(2); NDAs; ANDA.
• 2. Leads and ensures implementation of the planning, writing and review of all regulatory submissions to support PIND/IND/NDA/505(b)2; ANDA submissions including FDA meeting requests and packages.
• 3. Critically reviews and approves documentation from clinical development, non-clinical development, iPSP, Research and Development (R&D), Quality, Technical Operations, Labeling and other appropriate departments, internal and stakeholders, vendors and consultants.
• 4. Ensures that project timelines are developed and communicated; evaluates changes to maintain submission goals and timelines; communicates any delays along with the rationale.
• 5. Interprets regulations and guidance documents and provides strong regulatory leadership to project teams to ensure regulatory success.

Candidate Profile

• 1. Minimum of M.Pharm./M.Sc./Ph.D. with 5 to 10 years experience in the pharmaceutical industry, with at least USFDA working experience.
• 2. Strong analytical skills and business acumen specific to operational activities and product launches in generics.
• 3. Cross-functional collaboration skills with the ability to network with different functional areas and integrate cross-functional deliverables.
• 4. Sterile injectable and Solid Oral Dosage form registration experience candidates are required.
• 5. Proficiency in eCTD software, SPL, MS Office, MS Project.
• 6. Strong oral interpersonal and written communications skills.