Assistant Manager / Sr. Executive

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.