Sr Director Regulatory Affairs

2 weeks ago

Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

Confidential

Nordics - Stockholm

Join an ambitious team as Senior Regulatory Affairs Director in Stockholm, shaping regulatory strategies and building a new pharma portfolio for a leader in consumer health. Ready to drive impactful change? Apply now
Our client, an innovative leader in the consumer health space, is expanding into the pharmaceutical industry. They are seeking an experienced Senior Director Regulatory Affairs to establish and lead regulatory strategies, particularly for OTC products, as they build their pharmaceutical portfolio.

Senior Director Regulatory Affairs (OTC Pharmaceuticals)
Location: Stockholm (at least three days at the office)
Employment Type: Full-Time

Are you a strategic leader in regulatory affairs, passionate about making health solutions accessible? This is your chance to join a pioneering team where you'll shape the future of OTC pharmaceuticals for a company embarking on an exciting new journey.

Major Accountabilities
In this role, you will take ownership of regulatory activities across a range of areas, including MAs (MRP/DCP and national licenses), and oversee the marketing of cosmetics, medical devices, and food supplements across the Nordics.

Brand Responsibilities

  1. Collaborate with the MAH's global team and local colleagues to develop and implement regulatory strategies tailored to the Nordic region.
  2. Critically evaluate submission packages to meet Nordic regulatory standards, eliminating deficiencies prior to submission.
  3. Monitor and influence the assessment process to expedite approvals and optimize outcomes, including product labeling and supply continuity.
  4. Ensure compliance by communicating any regulatory changes to the global team and addressing critical issues such as batch recalls or release challenges.
  5. Submit and maintain local medicinal product information, including Patient Information Leaflets, SmPCs, packaging texts, RMPs, and Educational Material as needed.
  6. Lead the management of new MA submissions in collaboration with the global team, supporting Scientific Advice meetings, launches, and readiness initiatives.
  7. Provide strategic regulatory advice for divestments and in-licensing opportunities, considering Nordic-specific perspectives.

People Responsibilities

  1. Mentor the Regulatory team and occasionally deputize for the Responsible Person.
  2. Assist in coaching and developing team members, ensuring continuous learning and skill-building.
  3. Contribute to process improvements and inspection readiness for both internal audits and HA inspections.
  4. Drive personal development while fostering a collaborative, high-performing team culture.

Qualifications

  1. Education: Life Science Degree or equivalent, with broad regulatory experience in medicinal products. Experience in food supplements, cosmetics, and medical devices is advantageous.
  2. Experience: Minimum of 10 years in regulatory activities, with a focus on OTC products and commercial aspects within the pharmaceutical industry.

Skills:

  1. Strong negotiation and regulatory compliance skills.
  2. Proven leadership experience with a business-minded and detail-oriented approach.
  3. Knowledge of promotional compliance and best practices.
  4. Languages: Proficiency in a local Nordic language and English is essential.

What We Offer

  1. Competitive compensation and benefits package.
  2. A flexible, hybrid work environment promoting innovation and collaboration.
  3. Opportunities for professional development and leadership in building a regulatory team.

How to Apply
If this opportunity has captured your attention and you are truly ready to engage with genuine interest and commitment - contact Kristina Edholm at PharmaRelations for a confidential conversation. Send your CV and a cover letter detailing your expertise in regulatory affairs and your vision for this leadership role. Interviews are being conducted continuously.

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