Deputy Manager - Regulatory Affairs(Reg market) - Navi Mumbai

Titan Laboratories

Posted: 4 months ago
Openings: 10
Applicants: 0

Job Description

Dear All,

Greetings from Titan Laboratories Pvt Ltd !!

We are looking for Deputy Manager - Regulatory Affairs (Regulated market), where we are seeking a proactive and detail-oriented Regulatory Affairs professional to join our dynamic team!

Roles & Responsibilities -
1. Responsible for overseeing regulatory compliance aspects within company and shall be inline to the requirements of different regulatory bodies viz. EMA, MHRA, TGA, ANVISA, DIGIMED and other international regulatory agencies.

2. Lead a stagnant regulatory submission project through strategy to address agency concerns.

3. Managed the regulatory team to ensure the business maintains regulatory compliance and supports the company's product stewardship goals.

4. Provide assistance in creating a timeline for regulatory documents

5. Lead regulatory team to understand challenges and help facilitate aggressive global strategies to expedite time to

market 6 Co-ordination with Quality Assurance, Quality Control, R &D, Packing, production for technical data

7. Responsible for handling deviations & market complaints

8. Responsible for carrying out GAP analysis for identification and assessment of regulatory mitigation strategies for remediation

9. Ensuring preparation of documentation according to the requirements of MOH of the concerned country

10. Liaisoning with interdisciplinary groups such as R&D and PPIC so as to productively contribute to the Marketing requirements

Desired Skills:

1.Deep understanding of Global pharmaceutical regulations and guidelines.

2.Proven leadership skills in managing and motivating team.

3. Excellent communications skills

4. Problem/query solving skills