Director, RA, OSD/API

This is a fully remote position, open to applicants in United States, +2 more states.

📋 Description

• Spearhead strategic initiatives to guarantee regulatory compliance while promoting business growth across various regions.

• Formulate and execute regulatory strategies.

• Guide teams and cultivate relationships with regulatory agencies globally.

• Supervise regulatory compliance activities and offer expert advice.

• Ensure successful product submissions in multiple jurisdictions.

• Work in collaboration with cross-functional teams to define the regulatory strategy for product development, manufacturing, and commercialization.

• Shape global regulatory policy and foster innovation in regulatory methodologies.

⛳️ Requirements

• Advanced Degree with 6 years of experience, or Bachelor's Degree with 8 years of experience in pharmaceutical/medical device regulatory affairs, focusing on manufacturing operations.

• Preferred Fields of Study: Life Sciences, Pharmacy, Chemistry, Microbiology, or a related discipline.

• In-depth knowledge of global regulatory requirements, specifically FDA, EMA, and ICH guidelines.

• Proven success in regulatory submissions and interactions with agencies.

• Leadership experience in managing and mentoring multi-site teams.

• Experience in developing and implementing regulatory strategies.

• Established expertise in regulatory compliance and quality management systems.

• Advanced project management and organizational competencies.

• Exceptional verbal and written communication skills.

• Strong negotiation and influencing abilities.

• Capacity to work effectively within a matrix organization.

• Business acumen and strategic thinking skills.

• Proficiency in standard office technology and regulatory systems.

• Required fluency in English; proficiency in additional languages is a plus.

• Willingness to travel 25-50% of the time, primarily internationally.

• Experience with CDMO/pharmaceutical services is preferred.

• Awareness of current industry trends and active participation in professional associations (e.g., TOPRA, PDA).

🏝️ Benefits

• Accessibility/Disability Access.

• Professional development opportunities.