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:
Develops and implements submission strategies for PIND, 505(b)(2); NDAs; ANDA.
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.
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.
Ensures that project timelines are developed and communicated; evaluates changes to maintain submission goals and timelines; communicates any delays along with the rationale.
Interprets regulations and guidance documents and provides robust regulatory leadership to project teams to ensure regulatory success.
Candidate Profile:
Minimum of M.Pharm./M.Sc./Ph.D. with 5 to 10 years experience in the pharmaceutical industry, with at least USFDA working experience.
Robust analytical skills and business acumen specific to operational activities and product launches in generics.
Cross-functional collaboration skills with the ability to network with different functional areas and integrate cross-functional deliverables.
Sterile injectable and Solid Oral Dosage form registration experience candidates are required.
Proficiency in eCTD software, SPL, MS Office, MS Project.
Robust oral interpersonal and written communications skills.