- Monitor Regulatory Landscape: Stay updated on regulatory changes, trends, and developments specific to the pharmaceutical and medical device industries.
- Conduct Research: Research and analyze regulatory requirements, guidelines, and policies issued by regulatory authorities, such as the FDA (Food and Drug Administration), EMA (European Medicines Agency), and other relevant agencies worldwide.
- Assess Implications: Evaluate the potential impact of regulatory changes on pharmaceutical and medical device manufacturing, distribution, labeling, and marketing practices.
- Provide Insights and Analysis: Summarize and interpret regulatory information to provide actionable insights and recommendations to internal stakeholders, including regulatory affairs teams, compliance officers, and product development teams.
- Regulatory Compliance Support: Collaborate with cross-functional teams to ensure understanding and compliance with applicable regulations and requirements governing pharmaceutical and medical device products.
- Risk Assessment: Identify regulatory risks and vulnerabilities related to product development, manufacturing processes, and post-market surveillance. Propose strategies to address and mitigate regulatory risks effectively.
- Documentation and Reporting: Maintain accurate records of regulatory updates, analysis reports, and compliance documentation specific to pharmaceutical and medical device regulations. Prepare and present regulatory intelligence reports as needed.
- Stay Informed: Continuously monitor industry best practices, emerging trends, and regulatory enforcement actions relevant to pharmaceuticals and medical devices. Provide training and updates to internal stakeholders as necessary.
- Bachelor's degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related field. Advanced degree or professional certification (e.g., RAC - Regulatory Affairs Certification) is preferred.
- Proven experience (typically 2-5 years) in regulatory affairs, regulatory compliance, or a related role within the pharmaceutical or medical device industry.
- Strong understanding of regulatory frameworks, laws, and compliance requirements governing pharmaceuticals and medical devices, including Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Quality Management Systems (QMS).
- Excellent research, analytical, and critical thinking skills with the ability to interpret complex regulatory information and assess its implications for product development and commercialization.
- Detail-oriented with strong organizational and documentation skills.
- Effective communication skills, both written and verbal, with the ability to convey regulatory insights and recommendations to diverse stakeholders.
- Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced, highly regulated environment.
- Proficiency in utilizing regulatory databases, research tools, and software applications for data analysis and reporting.
- Consulting experience with an ability to interface directly with clients
- Ability to work in an agile environment and critical thinking while working with customers to deliver the final solution
- Adept at conducting research
- Competencies with Powerpoint and advanced Excel
- Self motivated
- Advanced degree preferred
- Minimum of 4-6 years of work experience related within the pharmaceutical and/or medical device industry
- Prior lifesciences consulting experience especially leading projects within M&A, Regulatory Affairs, Labeling, and Supply Chain is preferred
- Competitive salary and benefits package
- Opportunity to work on groundbreaking projects with Top Organizations
- Professional development and growth opportunities.
- Hybrid work options
Sr. Regulatory Affairs - Hyderabad, India - Kamet Consulting Group
Description
Job Description:
It's an exciting time to join Kamet Consulting Group as we continue our hyper growth journey. We encourage entrepreneurial culture, spirit, which empowers individuals to think creatively, take initiatives, and drive innovative solutions.
We are looking for a Sr. Regulatory Affairs / Regulatory Intelligence Associate (Pharmaceutical and Medical Devices) specializing in Pharmaceuticals and Medical Devices supporting monitoring, analyzing, and interpreting regulatory changes and developments within the pharmaceutical and medical device industries. This position involves staying abreast of evolving regulatory requirements, guidelines, and standards to ensure compliance and mitigate regulatory risks for the organization.
This is an exciting opportunity to work within our management consulting directly interacting with customers to build bespoke solutions to solve their business problems. The candidate will collaborate with our content matter experts and consultants while gaining a detailed understanding of internal and external data sets (e.g., registrations data, health authority correspondence, regulatory intelligence, etc.)
Kamet Consulting Group is a Life Sciences Management Consulting firm providing Strategic Advisory, Implementation, Capability Building, and Outsourced Services to Pharmaceuticals, Medical Devices, Digital Health, and Consumer Health companies across their value chain.
Our expertise spans across organizational and functional areas of Deals, R&D, Clinical, Regulatory, Quality, Labeling, Safety, Supply Chain, and Commercial. We pride ourselves in bringing extensive experience and professionalism to every engagement and customize our support to our client's individual needs and opportunities. We encourage entrepreneurial culture, spirit, which empowers individuals to think creatively, take initiatives, and drive innovative solutions.
At Kamet Consulting Group, we strive to create a strong and inclusive workforce by actively seeking a diverse pool of applicants. We firmly believe in providing equal opportunities to all qualified candidates, without any discrimination based on factors such as race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Responsibilities
Qualifications and Skills:
Other skills
Required Qualifications:
Benefits:
How to Apply:
We thank all applicants for their interest; however, only those selected for an interview will be contacted.