Senior Manager Regulatory Affairs

GenSearch; Nordrhein-Westfalen; Hybrid; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

A leading biotechnology company seeks a Senior Manager in Regulatory Affairs to oversee regulatory activities for new and approved products. The role combines operational and strategic components, requiring extensive experience in EU and Global Regulatory Affairs, particularly in ATMPs and biologics. Candidates should possess strong communication and organizational skills, with the ability to influence across a dynamic organization. Remote work is possible 50% of the time.

Qualifikationen

• At least 8 years of relevant regulatory and drug development experience in EU and Global Regulatory Affairs.
• Proven track record in the field of ATMPs and/or biologics.
• Hands on and self-starter with excellent organizational and communication skills.

Aufgaben

• Coordinate regulatory activities and implement registration strategy for product launches.
• Ensure compliance with pharmacovigilance and regulatory requirements.
• Liaise with health authorities and lead meetings regarding regulatory strategies.

Kenntnisse

Regulatory Affairs

Quality / CMC

Regulatory Submissions

Regulatory Information Management (RIM)

Communication Skills

Organizational Skills

Ausbildung

MD; Ph.D. or equivalent degree in medicine, pharmacy, biology, chemistry or related field

Advanced degree or certificate in regulatory science

Tools

VEEVA

Jobbeschreibung

Senior Manager Regulatory Affairs (m|f|d)

Our client is a fast-growing biotechnology company and a global market leader with numerous subsidiaries and distributors around the globe. The focus is on bringing cancer treatments and regenerative therapies to patients. The initial focus is on how difficult to treat cancers using CAR-T technology whilst exploring treatments for different Therapeutic Areas.

For this position we are looking for a candidate who likes the combination of operational and as well strategic component.

Your Tasks :

• Works with the technical leaders to make sure that the regulatory activities of other RA professionals related to new and approved products are done correctly, both on a domestic or international basis.
• Planning, carrying out and coordinating regulatory activities, as well as defining and implementing a registration strategy and planning for the launch of products.
• Overseeing validated regulatory document management system and product-specific attributes in compliance database.
• Overseeing the regulatory management system and setting up automated information workflows and identifying data that requires digitalization.
• Ensures that all pharmacovigilance / regulatory requirements and aspects of product safety and quality are closely monitored and fulfilled.
• Liaising with health authorities and following all the relevant rules. They also lead meetings with the Health Authority, including rehearsals under supervision or independently.
• May serve as Global RA program team representative for one or more programs through development, registration and approval / post approval.

Candidate profile :

• MD; Ph.D., or equivalent degree in medicine, pharmacy, biology, chemistry or a related field. An advanced degree or certificate in regulatory science will demonstrate your specific expertise in Regulatory Affairs.
• At least 8 years of relevant regulatory and drug development experience in EU and Global Regulatory Affairs with a proven track record in the field of ATMPs and / or biologics. EMEA and FDA experience.
• Excellent experience in Quality / CMC, regulatory submissions and / or Regulatory Information Management (RIM) systems. Experience with VEEVA is an advantage.
• Sound business judgment and collaborative skills, as well as proven ability to interact and influence at all levels of a dynamic, growing organization.
• Ability to build and maintain strong cross-functional relationships, to challenge traditional views while respecting best regulatory practices, and to present and argue regulatory strategies and approaches in a professional and respectful manner.
• Hands on and self-starter with excellent organizational and communication skills in English and basic skills in German.
• The job is located in North Rhine-Westphalian, Germany. Working remotely is possible 50% of the time with 2 or 3 days onsite.

Please do send your resume, only candidates who meet the required qualifications will be considered.

Regulatory Manager • North Rhine-Westphalia, Germany, Germany