Location: Bangalore, Karnataka
Industry Type: Pharma / Healthcare / Clinical Research
Experience Required: 5 Years
Qualification: Preferably MSc
Application Deadline: 30th October 2024
About Us
At Merck, our passion for science and technology drives our team of approximately 63,000 employees across 65 countries. We are committed to addressing some of today’s toughest challenges and creating sustainable solutions for life. From personalized treatments for serious diseases to empowering the scientific community, we strive to make a positive impact at every step of the healthcare journey.
Job Description
As a Specialist – Regulatory Affairs Manager, you will play a crucial role in preparing regulatory dossiers and executing actions to ensure product compliance and license security in various markets. You will work closely with representatives from multiple disciplines to develop and implement effective license management strategies.
Key Responsibilities:
- Prepare and manage regulatory documentation, including full international submissions and significant variations.
- Collaborate within a matrix organization to resolve complex tasks with guidance from senior License management personnel.
- Ensure compliance with health authorities’ requirements and maintain awareness of regulatory guidelines, policies, and regulations.
- Support life-cycle management activities across at least two regions (e.g., Europe, USA, International).
- Review and interpret necessary documents for product registration, including CPPs, GMP Certificates, and others.
- Maintain proactive communication regarding project timelines and potential risks.
- Utilize RIM, Vault, and EDMS RA applications effectively.
Candidate Profile
- Education: Degree in Life Sciences or a related field; MSc preferred.
- Experience: Minimum 5 years in a pharmaceutical environment, with at least 1 year in Regulatory Affairs.
- Skills:
- Knowledge of regulatory affairs, particularly post-approval changes and global regulatory procedures.
- Strong project management and documentation skills.
- Excellent written and spoken English.
- Ability to work collaboratively and communicate effectively across diverse teams.
Why Join Us?
At Merck, you will be part of a dynamic team that is passionate about making a difference in the lives of people around the world. You will have the opportunity to contribute to groundbreaking solutions in healthcare and be a part of a company that values innovation and collaboration.