Promea Pharma & Chemistry Regulatory Affairs Manager Job, Apply Online
Position Overview: We are seeking a dynamic and experienced Regulatory Affairs Manager with specialized expertise in injectables and/or biologics. The ideal candidate will play a pivotal role in ensuring regulatory compliance for our pharmaceutical and medical devices products.
Key Responsibilities:
Regulatory Compliance:
- Ensure adherence to local and international regulatory requirements for pharmaceutical products, with a focus on injectables and biologics.
- Collaborate with cross-functional teams to gather and evaluate regulatory information for new and existing formulations.
Formulation Expertise:
- Leverage in-depth knowledge of formulation processes to provide regulatory guidance and support during product development.
- Evaluate and communicate regulatory implications of formulation changes and improvements.
Submission Management:
- Prepare and manage regulatory submissions, including INDs, NDAs, CTDs and variations, ensuring timely and accurate submissions to regulatory agencies.
- Liaise with regulatory authorities to address queries and facilitate approvals.
Regulatory Intelligence:
- Stay abreast of evolving regulatory trends, guidelines, and requirements related to pharmaceutical formulations.
- Provide strategic insights on regulatory implications for new and existing products.
Cross-Functional Collaboration:
- Collaborate closely with R&D, Quality Assurance, and Production teams to align regulatory strategies with overall business objectives.
- Participate in project teams to provide regulatory input throughout product development.
Qualifications:
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related field.
- Proven experience in regulatory affairs within the pharmaceutical industry, with a focus on injectables and biologics.
- Strong understanding of formulation processes and their regulatory implications.
- Familiarity with global regulatory requirements and guidelines.
- Excellent communication and interpersonal skills.
- Ability to work collaboratively in a fast-paced, cross-functional environment.
- Detail-oriented with a commitment to ensuring regulatory compliance.
Apply for this position here.
Keywords: Promea Pharma, Chemistry, Regulatory Affairs Manager Job, Apply Online, injectables, biologics, regulatory compliance, formulation expertise, submission management, regulatory intelligence, cross-functional collaboration. Promea Pharma & Chemistry Regulatory Affairs Manager Job, Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
