Senior Regulatory Affairs Specialist

Sr. Analyst, Quality and Regulatory Affairs

It all started with a pharmacist and a dream 140 years ago. Today, Beiersdorf is a global company with iconic brands - Coppertone, Aquaphor, Eucerin, Elastoplast and NIVEA - focused on providing innovative, clinically-proven and safe skin and sun care solutions to more than 500 million consumers in over 200 countries - making people feel comfortable in their own skin.

At Beiersdorf, we care beyond skin. We care for people - our employees, our customers, our consumers and our communities - and our planet. We know that diversity of thought, backgrounds, experience, and perspective enriches our culture and fosters innovation and ingenuity. We know that responsibly sourced, sustainable products and packaging make for a more sustainable future. And we know that when your skin feels better, you feel better.

This position includes direct involvement of Quality and Regulatory troubleshooting. Reporting to the Head of RA/QA, the successful candidate will have working knowledge of Canadian regulatory and quality requirements and must be able to manage and coordinate pharmacovigilance for Canada, US and Beiersdorf global, including for Nivea and Coppertone. The role is divided into 3 parts of responsibilities (QA 50%, RA 20% and PV 30%).

Quality Assurance responsibilities (50%)

• Product releases in SAP system
• Obtaining required documents from manufacturing sites to release products
• Managing CAPAs
• Preparing investigation reports to be performed at warehouse, manufacturing sites
• Preparing monthly quality reports that reflect consumer and customer complaints, OSQ and Audit Plans
• Helping ensure that Global/Regional BDF QA requirements are implemented
• Assisting in performing quality store checks on an ongoing basis, documenting deficiencies, and preparing reports and assisting Quality management in the quality on shelf corporate initiative
• Evaluating destruction criteria for DIN and NHP returns through Phoenix system
• Contributing to continuous Improvement initiatives and participating in risk identification and contingency planning activities
• Supporting Sales with registering products at retail (W-M, SDM excel document)
• Supporting Customer Service with enquiries
• Providing VAS Production for Coppertone release timelines and interfacing with logistics/manufacturing/planning

Regulatory Affairs responsibilities (20%)

• Reviewing labels and advertising materials including print, digital etc for Regulatory compliance
• Preparing licensing submission documents and compiling and preparing DIN/NHP guidance's for launches
• Assisting in managing claims support and interfacing with Hamburg, US and Coppertone R&D department
• Assisting in training BDF employees and external agencies

Pharmacovigilance responsibilities (30%)

• Handling pharmacovigilance for Canada and supporting the Head of RA/QA in the investigation of consumer complaints and/or adverse events
• Processing of individual case safety reports, and basic knowledge in aggregate reports, ICSRs, DSURs, in compliance with Regulatory authorities
• Providing monthly Reverse Supply Agreement reports
• Supporting PV Audit preparation
• Monthly meeting with Med Affairs for AE reported in US and Canada
• Generating monthly AR reports to Med Affairs
• Providing training on PV to BDF Canada employees

Do you possess…

• University degree in Science or relevant field of study and ideally a post graduate degree in Regulatory Affairs
• 1-2 years Health Canada submission experience (includes NHP, DIN and Medical Device submissions)
• Working knowledge of and ability to interpret the Canadian Food and Drugs Act and Regulations and Medical Device Regulations as well as Health Canada policies and guidelines
• Working knowledge in using MedDRA and WHO drug dictionary to correctly code adverse event and work with external medical advisor to get medical insight on safety and efficacy of products
• Working knowledge in writing concise medical narratives and preparing Med Watch and CIOMS forms
• Strong technical knowledge of pharmaceutical manufacturing, quality assurance, GMP, ISO, ICH Guidelines
• Good written and verbal communication skills, excellent interpersonal and collaboration skills
• Strong organization skills and ability to prioritize workload
• Accuracy and attention to detail, as well as an ability to deal with ambiguity
• Proficient computer skills including MS Office Applications
• Ability to work independently and self-motivated to achieve results
• Strong critical thinking and problem solving skills
• Intellectual curiosity for keeping abreast of changing regulations and policies to ensure compliance

Experience, skills and competencies that lend themselves to this role

We know that experience comes in all forms and we're not necessarily looking for individuals who can hit the ground running ('check all the boxes') but may bring a unique blend of competence and capabilities that can grow into a role and/or bring news skills to the team.

A welcoming workplace that offers personal and professional growth for all individuals

At Beiersdorf, you'll find:

• A welcoming workplace that fosters diversity, inclusion and belonging where every team member feels valued, respected, and supported
• Nimble teams that enjoy challenging work and the ability to make an impact
• A dynamic community of life-long learners that values acumen, aptitude and the ability to learn as well as hard skills and established expertise
• A purpose-led company that cares about your personal and professional development with the right balance of structure and flexibility to thrive
• A collaborative culture that leads with care, trust, simplicity and courage

Unique benefits that consider the whole person

We understand that you have a life outside of work, and we support you with unique benefits including:

• Generous and flexible vacation policy
• Summer Friday hours
• Comprehensive Wellness and Benefits program
• Growing number of Employee Resource Groups or affinity groups - to foster meaningful connections and belonging with other colleagues
• Dynamic work model - a hybrid of in-office collaboration (3 days/week) and remote focused work days