Executive - Regulatory Affairs (Plmds)

5 months ago

Chennai Tamil Nadu, India ClinChoice Full time

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.

**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.
- Continuous improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities.
- Support activities related to 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 the basic team effectiveness skills like commitment, feedback, trust, and teamwork.
- Performs work in a structured environment under direction from supervisor.
- Exercises judgment to complete assigned tasks and has significant reliance on supervisor.
- Uses established procedures to perform assigned tasks.
- Participates and contributes as a team member and is 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 on the tools used in regulatory activities like publishing, artwork, change control management.
- Experience in managing a matrix environment.
- Proven experience in decision making and 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**:
**Who will you be working for?**

**About ClinChoice**:
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

**Our Company Ethos**:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

**Key words**: Executive Regulatory Affairs, Regulatory Affairs, Reg Affairs, RA, Regulatory, PLMDS, Clinical Trials, Clinical Research, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated

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