ClinChoice Regulatory Affairs Vacancy! BPharm & MPharm Apply
Executive – Regulatory Affairs (PLMDS)
at ClinChoice – Chennai, India
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds. ClinChoice is searching for an Executive – Regulatory Affairs (PLMDS) to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with client counter-parts.
Main Job Tasks and Responsibilities:
- Complete the assigned activities diligently, by using appropriate client-specific standards and tools, confirming to regulatory submission milestones and applicable regulatory obligations.
- Provide operational support within the team to execute designated tasks associated with submission.
- Accountable for delivering designated submissions with quality and timely as per applicable policy, SOP/Work instructions, guidelines, or service level agreement.
- Commit to completing required on-the-job training courses to ensure training compliance is preserved.
- Continuously improve selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities.
- Support activities related to the Product License Portfolio in a timely and quality manner.
- Execute the assigned activities to ensure completion of project tasks and/or milestones.
- Capable of understanding and implementing basic team effectiveness skills like commitment, feedback, trust, and teamwork.
- Apply necessary technical skills to complete the assigned regulatory operational activities to support submissions to global health authorities.
- Perform work in a structured environment under the direction of a supervisor.
- Exercise judgment to complete assigned tasks and has significant reliance on the supervisor.
- Use established procedures to perform assigned tasks.
- Participate and contribute as a team member and be responsible for certain team deliverables.
Education, Experience, and Skills:
- Bachelor’s / Master’s Degree in Pharmacy / Science or other relevant domains.
- Fundamental working experience of 2-4 years in RA/QA/AR&D/R&D/QC requirements.
- Awareness of the tools used in regulatory activities like publishing, artwork, and change control management.
- Experience in managing a matrix environment.
- Proven experience in decision-making and meeting tight deadlines.
- Technically adept at using IT systems and software.
- Fast learner with proven ability to adapt to changing demands.
- Good knowledge of English, spoken and written.
The Application Process:
Once you have submitted your CV, you will receive an acknowledgment that we received it. If you meet the requirements, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Link to original notification to apply: Apply Here
Keywords: Executive Regulatory Affairs, PLMDS, ClinChoice, Job Posting, Regulatory submission, Global CRO. ClinChoice Regulatory Affairs Vacancy! BPharm & MPharm Apply. 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.
