Job Title: Regulatory Affairs (Labeling) - US Market
Company: Leading Pharmaceutical company.
No. of Positions: 6
Division: R&D (OSD)
Department: Regulatory Affairs
Qualification: B.Pharma/ M.Pharma
Years of Experience: 1 to 7 Years.
Interested candidates can reach me through
Contact person: Mr. B.Saravana Prabhu
call : 7676636384
whats app: 9790291595.
Profile we are looking for:
Roles & Responsibilities:
- Candidates should have core labeling experience in RA
- Candidates who are working in consulting firms are not suitable
- Candidate should have experience in preparation of artworks & pack inserts.
- Three years of service agreement will be there for candidates with experience of 4 years and below.
- Development and approval of Artworks including required change management activities.
- Timely submission of labeling (artworks) with high level of quality and accuracy for new submissions, amendments and supplements.
- Co-ordinate with cross functional and global teams for ensuring the timely availability and release of approved artworks to meet the commercial requirements.
- Planning and maintenance of labeling tracker to ensure the availability of approved artworks as per timeline.
- Complies with all standards, procedures and policies for regulatory labeling submissions set forth for the Regulatory Function.
- Remains knowledgeable about current regulations and guidance of regulatory labeling to perform day to day regulatory labeling activities.
- Responsible for ensuring compliance to company submission standards, policies and procedures.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Packaging
Role: Packaging Development Executive/Manager
Employment Type: Full Time, Permanent