Planet Pharma
Job Description
Manager of Regulatory Affairs
The Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments, and obtain and maintain National Health Authority approvals for investigational products. The position may also undertake regulatory intelligence and research supporting company decision-making. Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Such submissions may include Clinical, Preclinical, or CMC content.
Correspond and collaborate with company colleagues and departments to achieve alignment.
Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams.
Perform regulatory research to inform business strategy. Assess and communicate risks.
Assure that there are no significant interruptions to the business due to regulatory compliance issues.
Collaborates across the organization at all levels, across functional groups, and with executive management.
Develop regulatory strategies to inform associated budgets, tools and specialized support. necessary for efficient operations. Required Skills, Experience and Education:
Bachelor's Degree in a relevant field and at least 3 years of direct Regulatory experience.
Strong working knowledge of US FDA Pharmaceutical regulations and guidance.
Proven track record of successful submissions within a regulatory environment.
Exceptionally strong team player with excellent interpersonal and communication skills.
Detail-oriented with strong organizational skills and high-quality standards. Preferred Skills:
Knowledge of EU EMA Pharmaceutical regulations and guidance preferred.
Direct experience with IND/NDA filings.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Manager of Regulatory Affairs
The Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments, and obtain and maintain National Health Authority approvals for investigational products. The position may also undertake regulatory intelligence and research supporting company decision-making. Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Such submissions may include Clinical, Preclinical, or CMC content.
Correspond and collaborate with company colleagues and departments to achieve alignment.
Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams.
Perform regulatory research to inform business strategy. Assess and communicate risks.
Assure that there are no significant interruptions to the business due to regulatory compliance issues.
Collaborates across the organization at all levels, across functional groups, and with executive management.
Develop regulatory strategies to inform associated budgets, tools and specialized support. necessary for efficient operations. Required Skills, Experience and Education:
Bachelor's Degree in a relevant field and at least 3 years of direct Regulatory experience.
Strong working knowledge of US FDA Pharmaceutical regulations and guidance.
Proven track record of successful submissions within a regulatory environment.
Exceptionally strong team player with excellent interpersonal and communication skills.
Detail-oriented with strong organizational skills and high-quality standards. Preferred Skills:
Knowledge of EU EMA Pharmaceutical regulations and guidance preferred.
Direct experience with IND/NDA filings.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.