Tiefenbacher Laboratories Hiring for Regulatory Affairs – (Formulation)

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.

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.