Job Description

Job Title Sr Regulatory Affairs Associate

Location(s) Mumbai

Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere.

Our dedicated team of about 16,000 employees worldwide, pioneers scientific technologies for better detection, imaging, and informatics to help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.

If you are seeking a meaningful, impactful, and stimulating career, look no further.

Sr Associate, REGULATORY AFFAIRS

PerkinElmer is a global technology company focused on improving the health and safety of people and the environment. The Regulatory Affairs Manager will support our Diagnostics Business that focuses on products targeted to improve human health. He/she will represent regulatory submissions on global cross-functional teams providing guidance on US regulatory requirements, review data for sufficiency and lead registration related negotiations.

Key Responsibilities:

• Supports international registration of new products which may include US, Canada, EU and rest-of-world submission activities.
• Supports post-approval reports, annual reports, export certificates, and establishment registrations and device listings.
• Supports cross functional project teams to provide strategic and tactical guidance to meet Health Authority requirements, including but not limited to authorship or review of required documentation, impact assessment of changes to released products, labeling
• Supports global Regulatory teams and/or in-country dealers/representatives with regulatory registrations of US-manufactured IVD products
• Maintains knowledge of US IVD, Health Canada and EU regulations and applicable guidances

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job at any time.

Basic Qualifications:

• Bachelors Degree in life science related field
• 3 years of experience in a Quality, Regulatory or Clinical role

Preferred Qualifications:

• Working knowledge of US FDA, Health Canada and EU regulations and guidance documents
• Previous experience supporting international registrations a plus
• Limited travel (up to 10-15% of the time, or as circumstances dictate)
• Excellent interpersonal, verbal and written communication skills (in English)
• Excellent time management, organizational, negotiation, and problem solving skills
• Ability to work independently and in a matrixed organizational structure, developing strong relationships with peers and levels of management