Dy. Manager / Manager - Regulatory Affairs (Reg market) - Navi Mumbai
- Titan Laboratories
- 12 - 17 years
- Mumbai
- 2 months ago
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Job Description
Dear All,
Greetings from Titan Laboratories Pvt Ltd !!
We are looking for Deputy Manager / Manager - Regulatory Affairs, 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 documents5. Lead regulatory team to understand challenges and help facilitate aggressive global strategies to expedite time tomarket 6 Co-ordination with Quality Assurance, Quality Control, R &D, Packing, production for technical data7. Responsible for handling deviations & market complaints8. Responsible for carrying out GAP analysis for identification and assessment of regulatory mitigation strategies for remediation9. Ensuring preparation of documentation according to the requirements of MOH of the concerned country10. 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 skills4. Problem/query solving skills
Interested candidates share their resume on contact details -
Mail ID - va*******b@ti********a.com
or call on contact - 022 - 6785 7000 (Ext 725).
If you have good references you can share on above details.
Thanks & Regards,
Vaibhavi Behere
HR Department
Titan Laboratories Pvt Ltd
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Legal & RegulatoryRole Category: Corporate AffairsRole: Head - Regulatory AffairsEmployement Type: Full timeContact Details:
Company: Titan LaboratoriesLocation(s): Mumbai
Keyskills: Regulatory Affairs Drug Regulatory Affairs Europe Regulatory Compliance Head Regulatory RA
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