Location: US Headquarters are in Waltham, MA
Position may be remote with required travel as needed.
SUMMARY:
The Regulatory Affairs Associate Director will be responsible for ensuring that all non-prescription drug and cosmetic Over the Counter (OTC) products meet the required regulatory standards and compliance. This role involves collaborating with cross-functional teams to facilitate product development, maintain compliance throughout the product lifecycle, and liaise with regulatory agencies, local, state and federal.
ESSENTIAL FUNCTIONS:
- Regulatory Strategy Development: Develop and implement regulatory strategies for OTC products (drugs and cosmetics), ensuring alignment with business goals and compliance with applicable regulations.
- Product Development Support: Collaborate with R&D, marketing, and quality assurance teams during product development to ensure regulatory considerations are integrated.
- Labeling Compliance: Ensure that product labeling, advertising, and promotional materials comply with regulatory standards and guidelines.
- Monitoring Regulations: Stay updated on changes to regulations, guidelines, and industry standards affecting OTC products and communicate these changes to relevant stakeholders.
- Risk Assessment: Conduct risk assessments and provide recommendations to mitigate regulatory risks associated with product development and marketing.
- Cross-Functional Collaboration: Work with internal teams to prepare for audits, inspections, and regulatory meetings.
- Training and Guidance: Provide training and guidance on regulatory requirements to internal teams to foster a culture of compliance.
QUALIFICATIONS:
EDUCATION AND EXPERIENCE:
- A Bachelor’s or advanced degree in a relevant scientific field.
- Extensive experience (5 or more years) in regulatory affairs, specifically with OTC products; experience with prescription and/or medical device products is a plus.
- In-depth knowledge of US regulations at local, state and federal levels related to OTC drugs, labeling, and advertising.
- Strong leadership, communication and interpersonal skills.
- Proven experience in leading and managing projects and teams.
- Ability to analyze complex regulatory issues and develop effective solutions.
- Excellent organizational and project management skills.
PHYSICAL DEMANDS AND WORK ENVIRONMENT:
- This position may require occasional travel for regulatory meetings or industry conferences.
- Prolonged periods sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at a time.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of his job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EEO STATEMENT
Thea Pharma Inc. is proud to be an Equal Employment Opportunity employer. At Thea, we not only support the diversity of our employee population, we celebrate the way our team member’s unique backgrounds and experiences contribute to the success of our company. Thea does not discriminate on the basis of race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Thea Pharma Inc. does not tolerate harassment or discrimination of any kind.
BENEFITS AND PERKS
Thea offers a full suite of employee benefits, including employer-paid health insurance, a generous schedule of paid time off (PTO), Life and Disability insurance, and a 401K retirement program. Thea is a flexible and entrepreneurial work environment where you will enjoy an inclusive culture and the opportunity to have your voice and ideas directly shape the future of the company.
Your information will be kept confidential according to EEO Guidelines.