Position Overview:
We are currently seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team remotely. Joining our pharmaceutical startup means joining a team that values creativity, initiative, and ethics. With a commitment to nurturing talent from within, we offer clear pathways for career advancement across various functions and disciplines. As our company continues to grow and evolve, so do the opportunities for our dedicated team members to thrive and excel in their careers.
Responsibilities include:
Lead the preparation, review, and submission of regulatory documents to health authorities.
Provide regulatory guidance and support to cross-functional teams throughout the product life cycle, including product development and post-marketing activities.
Conduct regulatory intelligence research to stay informed about changes in regulations, guidelines, and industry best practices relevant to our products and therapeutic areas.
Review and approve labelling, packaging, and promotional materials to ensure compliance with regulatory requirements.
Liaise with regulatory agencies and respond to queries and requests for information in a timely and professional manner.
Develop and maintain regulatory strategies and plans for product development, registration, and lifecycle management.
Qualifications:
BPharm or MPharm
Minimum of 2 years of experience in regulatory affairs within the pharmaceutical industry.
Strong knowledge of both Indian and global regulatory requirements preferred.
Excellent written and verbal communication skills, with the ability to communicate complex regulatory concepts effectively.
Proven ability to work independently and remotely, managing multiple projects and priorities effectively.
Strong attention to detail and analytical skills, with the ability to interpret and apply regulatory requirements to specific situations.
Prior experience working remotely or in a virtual team environment is preferred but not required.
How to Apply:
Interested candidates should submit the following to deepali@ahimsapharmaceuticals.com:
1. CV
2. salary expectations
3. In lieu of a cover letter, please submit a 500-600 word essay explaining how trustworthiness can be measured at the level of individual employees as well as for the organisation as a whole.