Our client, an emerging animal health company, is currently seeking a Regulatory Affairs Manager to provide regulatory leadership, develop strategies, and provide operational direction to all regulatory projects with the intent to gain global marketing approval.
The Regulatory Affairs Manager will be responsible for global regulatory affairs for all feed additive and Microbiome Therapy products in commercial or research development (pre and post market approval). This individual will be hands on and directly responsible for the registration of the company’s animal health pipeline.
- Develops the global regulatory strategy for individual programs including preparing the programs for successful registration in all major global markets;
- Defines country-specific regulatory strategies for all programs assessing optimal route to approval, leading communication and negotiation with global regulatory agencies, and leading the company’s effort in definitive submissions;
- Prepares briefing and regulatory documents for regulatory agencies;
- Ensures that all nonclinical and clinical programs are appropriately informed and structured to meet Canada, US and EMEA, Latino America, and Asian regulatory requirements;
- Ensures that all the manufacturing and quality programs relevant to the manufacturing and controls of the products are appropriately structured to meet Canada, US, EU regulatory requirements;
- Develops, maintains and builds strong relationships with internal and external key stakeholders.
- An advanced degree (PhD, MD, MSc, MPH, PharmD) in Microbiology, Nutrition, Animal Health or Veterinary related pharmaceutical science is required;
- Minimum of five (5+) years of progressively responsible experience in regulatory affairs within the animal health industry, or equivalent;
- Must have at least five (5) years of experience in a management role;
- Good understanding of Biological and Natural Health Product manufacturing;
- Ability to apply knowledge of regulatory guidelines both strategically and operationally;
- Experience leading regulatory aspects of product development through market launch;
- Must have extensive knowledge of the regulations, regulatory process and requirements in all major global markets;
- Proven leader with a strong results orientation, positive “hands on” attitude and a sense of urgency to get things done;
- Strong written and oral communication and listening skills;
- Ability to travel up to 20% [domestic and international].
If you are interested in this opportunity, please submit your resume to Céline Chabée at firstname.lastname@example.org.
Only qualified candidates will be contacted.