Job Opportunity Regulatory Affairs Executive / Senior Executive – at FinOrion Pharma India
Job Opportunity: Executive / Senior Executive – Regulatory Affairs at FinOrion Pharma India Pvt. Ltd.
Are you a skilled professional in the field of Regulatory Affairs, seeking an inspiring role in the pharmaceutical industry? FinOrion Pharma India Pvt. Ltd. is actively searching for an Executive / Senior Executive to join their Regulatory Affairs department. This position offers the opportunity to work in Mumbai, contributing to the Life Cycle Management of assigned products in compliance with EU and other country regulations.
Are you ready to make an impact in the pharmaceutical industry? FinOrion Pharma India Pvt. Ltd. invites you to be part of their Regulatory Affairs team as an Executive / Senior Executive. This role involves managing the life cycle of products according to rigorous regulatory standards, ensuring compliance, and contributing to the overall success of the company.
Description of Position
Position: Executive / Senior Executive – Regulatory Affairs
Location: Mumbai, India
Responsibilities
As an Executive / Senior Executive in the Regulatory Affairs department, your responsibilities will include:
- Managing the Life Cycle Management of assigned products in accordance with EU and other relevant country regulations.
- Ensuring compliance of products with regulatory authority regulations, decisions, decrees, and quality system requirements.
- Preparing, compiling, and submitting maintenance activities (renewals and variations) based on company plans and regulatory authority guidelines.
- Coordinating administrative tasks such as translations, legalization, and CPP (Certificate of Pharmaceutical Product) to facilitate submissions.
- Evaluating change control activities.
- Keeping Orion’s internal regulatory systems up to date and accurate.
- Maintaining a complete regulatory archive and ensuring current licenses and labeling are up-to-date.
- Coordinating with internal and external stakeholders to effectively implement changes.
- Following and complying with internal policies and procedures.
We Offer
By joining FinOrion Pharma India Pvt. Ltd., you’ll enjoy a range of benefits:
- An excellent opportunity to work in a pivotal role in Regulatory Affairs.
- The chance to be part of the globally operating Orion Group’s wholly-owned subsidiary.
- Utilize your strengths with the support of professionals.
- A flexible, high-spirited working environment with a hybrid work policy.
- Good work-life balance and transparent processes.
- The opportunity to contribute to meaningful healthcare advancements.
Requirements
To thrive in this role, candidates should possess:
- A Bachelor’s or Master’s degree in Pharmacy from a reputable college or university.
- A minimum of 4 years of Regulatory Affairs experience.
- Experience in product life cycle management is advantageous.
- Strong knowledge of EU requirements and ICH (International Council for Harmonisation) guidelines.
- Familiarity with Microsoft Office applications.
- Attention to detail and accuracy in work.
- Ability to work independently and as part of a team.
- Regulatory awareness of current regulations and upcoming changes.
Application Process
To apply, please complete the Candidate Information Form and email your updated CV to [email protected] with a copy to [email protected] by August 31, 2023.
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