Tiefenbacher Laboratories is inviting applications for
Regulatory Affairs (Formulation) positions. If you are a qualified professional with extensive experience in
regulatory submissions and market authorizations, this opportunity offers a significant career advancement in the pharmaceutical sector. Join a company that values expertise, collaboration, and innovation in regulatory affairs.
Job Details for Regulatory Affairs (Formulation) – Dy. Manager/Manager
Location: Hyderabad, Telangana
Experience: 10-14 years in regulatory affairs (formulation)
Positions Available: Dy. Manager/Manager
Department: Regulatory Affairs - Formulation
About Tiefenbacher Laboratories
Tiefenbacher Laboratories specializes in formulating high-quality, compliant products for various international markets. Tiefenbacher’s commitment to rigorous regulatory adherence and market-specific formulation expertise makes it a desirable workplace for skilled professionals in the pharma industry.
Key Responsibilities
In this
Regulatory Affairs (Formulation) Manager role, the selected candidate will play a vital role in ensuring regulatory compliance across international markets. Key responsibilities include:
- Submission Management: Independently handle CTD and ACTD submissions specific to Rest of World (ROW) markets, including the GCC, MENA region, ASEAN, and CIS.
- Regulatory Compliance: Ensure compliance with Good Manufacturing Practices (GMP) and manage product licenses and Certificates of Pharmaceutical Product (COPP) for ROW submissions.
- Strategic Filings for Market Authorization: Develop and implement filing strategies for market authorization in India, working closely with the Drug Controller General of India (DCGI) for approvals.
- Collaboration with Business Development: Coordinate with the business development team to design effective filing strategies tailored to specific markets, addressing client and customer needs.
- Stakeholder Interaction: Represent the company in Subject Expert Committee (SEC) meetings with DCGI when required.
- Travel: Willingness to travel as needed to oversee regulatory processes or attend meetings with regulatory authorities and clients.
Qualifications and Skills
- Educational Background: Graduate or Postgraduate in Pharmacy or Life Sciences.
- Experience: 10-14 years of proven experience in regulatory affairs with a specialization in formulation.
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Application Process
To apply for this role, please send your CV to
k.surendra@tiefenbacher.com.
For inquiries, contact
+91-8418694444 or visit us at
Survey No. 42, Gaddapotharam, Kazipal Industrial Area, Sanga Reddy Dist., Hyderabad, Telangana.
https://pharmastuff.org.in/job/tiefenbacher-laboratories-hiring-regulatory-affairs-formulation
