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.
- 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.
- 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.
- 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.
- Stay abreast of evolving regulatory trends, guidelines, and requirements related to pharmaceutical formulations.
- Provide strategic insights on regulatory implications for new and existing products.
- 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.
- 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.
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