Naprod Life Sciences - Senior Manager - Regulatory Affairs

Regulatory Affairs Senior Manager (Europe)

We are looking to employ an enthusiastic and driven Sr. Manager - RA (EU Market) for Mumbai (Andheri - Marol) Location.

JD's :

- Hands on experience in preparation and timely submission of Europe market specifically in the countries.

- Comprehensive and up-to-date knowledge on regulatory guidelines/requirements.

- Identify relevant guidance documents, international standards and provide interpretive assistance.

- Providing necessary regulatory inputs to different cross functional teams during different stages of product development and manufacturing.

- Experience and knowledge on life cycle management for the products filed in Europe Market.

- Review of technical (developmental and plant) documentations required for dossier submission.

- Responsible to work on deadlines, in a fairly high pressure business environment while being a good team lead.

- Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy

- Lead team for timely results

- Experience in balancing customer facing role and work assessments

- Self-starter and have analytical, prioritization skills.

- Good analytical, Communication skills and business acumen.

Required Candidate profile :

- Exposure in Regulatory approved companies from ANVIMA, ANVISA, WHO, FDA etc.

- Limited query from Agents & MOH.

- Support Business development team by getting on time registrations.