Pharma Regulatory Associate Job at Syneos Health, Apply Now!
Looking for a Regulatory Associate job in a leading biopharmaceutical solutions company? Syneos Health is hiring professionals with expertise in CMC variations, regulatory guidelines, and RIM systems (Veeva RIMS, Trackwise). Join a globally recognized organization and accelerate your career in clinical development and regulatory affairs.
- Job Position: Regulatory Associate/Sr Regulatory Associate
- Location: Gurugram, India, Asia-Pacific
- Job ID: 25002287
About the Company
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Why Syneos Health
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Essential Functions of MPharm/MSc Regulatory Associate Job
- Prepares Module 3 sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities, according to current government regulations and guidelines.
- Prepares and submits full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations.
- Experience of performing activities in Veeva RIMS, including creation of objectives and submission content plans, would be preferred.
- Undertakes information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures.
- Undertake project specific activities with minimal supervision from senior colleagues within cost and time estimates/contracts.
Qualifications for MPharm/MSc Regulatory Associate Job
- MS/M.Pharm, or equivalent combination of education and experience.
- Minimum 6 months of experience for Regulatory Associate and minimum 1.5 years of experience for Sr Regulatory Associate role.
- Excellent interpersonal / communication skills.
- Advanced skills in Microsoft Office Applications.
- Hands-on experience on RIM systems such as Veeva RIMS and Trackwise, would be preferred.
- Strong analytical skills.
- Ability to work independently and to understand and carry out detailed instructions.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
Keywords: Regulatory Associate, Sr Regulatory Associate, Clinical Development, Biopharmaceutical Solutions, Regulatory Guidelines, Veeva RIMS, Trackwise, Syneos Health. Pharma Regulatory Associate Job at Syneos Health, Apply Now!
