Associate Manager | Regulatory Affair

Main responsibilities:
• Maintaining a deep understanding of new and existing regulations that may impact their organization’s products and processes
• Using that understanding to standardize all business operations and establish clear, documented protocols
• Explaining regulations, procedures, and policies to all employees and stakeholders as necessary
• Maintaining data and files for future reference, particularly in the event of an audit by a regulatory agency
• Reviewing marketing, legal, and technical documentation (including case files and clinical research reports) to assess compliance
• Implementing internal audits of products and protocols to identify areas of weakness, and putting in place corrective measures
• Regularly reporting on compliance status and measures to both internal and external parties
• Preparing for and facilitating third-party audits as necessary
• Acting as a liaison between their organization and state, local, federal, and international agencies to submit required forms and paperwork
• In addition to the responsibilities listed above, regulatory specialists are also often leveraged at various stages throughout the product development process to ensure compliance every step of the way, from research and development through manufacturing, marketing, and final approval.

Qualifications and Experience:
• Graduation or Master’s in Pharmacy, Chemistry, Bio-technology or any relevant field
• 10+years of experience of relevant experiences in Regulatory Affair department

Essential Skills:
• Attention to detail: By nature, the work expected of a regulatory affairs specialist can be rather regimented, requiring that particular processes and protocols be followed at all times. That’s why attention to detail is so critical: One misstep can put lives and the organization’s reputation at risk.
• Analytical skills: While regulatory affairs specialists are not analysts, collecting and analysing data to identify patterns and potential liabilities is still often a part of the job description for many.
• Communication skills: While regulatory expertise is essential to working in regulatory affairs, it’s useless if you cannot effectively communicate with those around you, whether they be co-workers, team members, vendors, or customers.
• Project management: Regulatory affairs is, in many regards, very similar to project management, requiring the planning and coordination of many moving pieces to achieve the desired result. (This is especially true during the development and launch of new products and services.) Therefore, skills like project and time management are essential.
• Domain expertise: To be effective in the role, a regulatory affairs specialist must be an expert in the domain of their company or organization. This means having a deep understanding not just of the products or services offered by the company, but also of the broader industry in which the company operates and the agencies that regulate it.
• Sense of mission: The best regulatory affairs specialists—those that truly make a difference—do not simply see regulatory affairs as a job. They understand the importance of their role in protecting consumers from danger and are compelled by this mission to reduce harm.

What we offer:
• With us, there are always opportunities to break new ground.
• We empower you to fulfil your desires, and our diverse businesses offer various career moves to seek new horizons.
• We trust you with responsibility early on and support you to draw your own career map that is responsive to your ambitions and priorities in life.
• Join us and bring your curiosity to life!
• You'll fit right in at Meteoric Biopharmaceuticals where we have surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

This role description is not an exhaustive list of all the duties and responsibilities and is subject to change in accordance with the needs of the Organization