Description:
Job Title: Senior Director/ Head of Regulatory Affairs

Location: Munich, Germany

Start: Per Candidate Availability

Contract: Permanent

TalentSource is currently looking for one Senior Director/ Head of Regulatory Affairs to strengthen the Global R&D Unit at one of our TOP Pharmaceutical client Companies in Munich, Germany.

Primary Responsibilities

Registration:

• Primary contact with national authorities for regulatory issues for Sponsor's products. Liaison with Sponsor International Regulatory Affairs regarding submissions relating to Sponsor's products.
• Submission and follow-up of all regulatory submissions to national authority, including submission of Clinical Trial applications, amendments, notification, etc and new or amended SmPC's to national compendia, variations, etc.
• Obtain and maintain necessary regulatory-associated licenses with national agencies required for Sponsor's business.
• Obtaining, providing and interpreting national regulatory intelligence with International Regulatory Affairs; will require interaction (networking) with Health Authorities and may require participation with national committees.

Regulatory Compliance:

• As deputy Commissioner of the graduated plan (Stufenplanbeauftragter) according to the German Drug Act (AMG) Section 63a ensures compliance with all safety relevant regulations applicable to this position.
• Ensure compliance within the company with all applicable (pharmaceutical) legislation (e.g. GMP/ GDP guidance, EFPIA/FSA codex) relevant to the position on national and international level.
• Coordination of local authority inspections or Sponsor internal audits on GxP.
• Preparation and maintenance of required and relevant local SOPs and associated process documents required internally and externally;
• Dissemination of new or amended product information to the local company employees.
• Coordination of record retention as required for regulatory affairs
• Review and approval of new or amended packaging components in line with the products' licenses for the products marketed locally.
• Support compliance with of GDP requirements if required.
• Represent, as appropriate, Sponsor Germany with national authorities on regulatory compliance.

Commercial Compliance:

• As Informationsbeauftragter (national qualified person for scientific service) according to the German Drug Act (AMG) Section 74a ensures compliance with all regulations applicable to this position, e.g. HWG, AMG.
• Support as appropriate the maintenance and operation of Sponsor Business Conduct.
• Contribute to and support the review and approval of promotional and non-promotional materials in accordance to Sponsor internal promotion guidelines, national legislation and Code of Practice.
• Provision of guidance and assistance to Commercial function during preparation of promotional materials.
• Provide Regulatory Affairs review and approval of any other activity specified under the local Code of Practice (interactions with HCPs, including consultancy/speaker contracts, grants and donations; advisory boards, non-HCP meetings)

Quality Assurance:

• Act as responsible person for Quality Assurance.
• Provision of compliance with applicable laws, regulations and internal procedures.
• Represent, as appropriate, Sponsor Germany with national authorities on quality matters

General Management and Administration:

• Line management of Regulatory Affairs team and control of the budget for this department
• Support and contribute to agreed cross-functional and Affiliate leadership matters.
• Perform required reporting obligations, internally and externally.
• Support individuals, teams, functions and external parties in the performance of their duties on behalf of the German Affiliate.
• Support Regulatory Affairs input to crisis and incident management and business continuity planning, as required.
• Represent regulatory affairs and Sponsor Germany with external parties, as appropriate and when required.

Professional Experience / Qualifications

• Extensive relevant industry experience in regulatory affairs and understanding of current trends in local and regional requirements.
• Experience in developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities
• Demonstrates strong leadership skills with a sphere of influence externally, cross-functionally and within the RA function
• Experience of and excellence in providing leadership and managing an experienced team.
• Degree in Pharmaceutical Sciences or equivalent discipline, An advanced degree is desirable.
• In-depth knowledge of national and international regulatory requirements for medicinal products.
• Extensive knowledge and experience in regulatory systems.
• Excellent written and verbal German and English communication skills.
• Excellent interpersonal skills.
• Ability to plan schedules and arrange own activities timely and efficiently.
• Excellent organization skills and ability to work on a number of projects with tight deadlines.
• Is recognized as a knowledgeable resource for regulatory advice for other functions and teams.
• Must be able to facilitate interactions with International Regulatory Affairs, other departments within the Company and with external parties (national authorities, trade associations, professional bodies, etc.)

If you would like to discuss the role before applying through the website, please contact alexander.sourounis@cromsource.com for more information or apply through https://www.talentsourcelifesciences.com/job-information/?job-id=Hq00001955

Why choose TalentSource Life Sciences/CROMSOURCE?

TalentSource Life Sciences is a fully dedicated flexible resourcing department at CROMSOURCE, a family owned international, full-service Contract Research Organisation. CROMSOURCE comes from the merger of MSOURCE and CROM and we have been supporting clients with outstanding clinical research and resourcing services since 1994. Successful growth has been achieved by putting high quality and client focus at the heart of everything we do and we are proud to partner with industry leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide.

Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our current below industry average turnover rates.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are experts providing experts - highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world.

Skills: Regulatory Affairs Associate, Regulatory Affairs Manager, Regulatory Affairs VP, Regulatory Location: Germany Share:

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