Role & Responsibilities

 

• Act as global regulatory lead for assigned projects, and define and execute regulatory strategy from clinical development up to marketing authorization and maintenance

• Provide regulatory guidance and support to cross-functional internal and client teams, including R&D, (non)clinical, CMC, safety

• Ensure compliance with regulatory requirements, including but not limited to FDA, EMA, and other international regulations

• Prepare and submit regulatory documents for various regulatory procedures, including pre-approval procedures (e.g. Orphan Drug Designations, Pediatric Plans, Scientific Advice, INDs, clinical trial applications, etc.), marketing authorization procedures (NDAs, BLAs, EU MAAs, and other regions), post-approval procedures (variations, renewals, etc.) and other regulatory filings

• Interact with regulatory agencies on behalf of the clients

• Interact with clients, lead meetings

• Keep up-to-date with changes in regulatory requirements and industry trends

• Develop and maintain relationships with key stakeholders, including regulatory agencies, consultants, and industry associations

• ·Set up, adjust and continuously optimize regulatory processes (SOPs, Work Instructions and company processes) and interfaces (internal and external); supervise vendors in regulatory affairs on behalf of Phortas

• Train and mentor junior regulatory affairs staff

• Contribute to continuous improvement initiatives within the regulatory affairs function

• Lead and manage other delegated regulatory affairs activities for the company

 

Relevant Skills & Knowledge

 

• Minimum of 8 years of experience in regulatory affairs in the pharmaceutical or biotech industry

• Strong understanding of FDA, EMA, and other international regulations

• Proven track record of successfully leading and managing regulatory affairs activities for new product development and product registration

• Excellent written and verbal communication skills

• Ability to work independently and as part of a team in a fast-paced environment

• Strong organizational and project management skills

• Ability to think strategically and make sound decisions

• Ability to effectively interact with internal and external stakeholders at all levels

• Experience with ATMPs and/or biologic products is a plus

• Previous experience in a life science consulting firm is a plus

• Ability to meet tight deadlines

• Excellent communication and interpersonal skills

 

• Fluency in English (written and verbal)

• Any additional language is a plus

• Willingness to travel internationally and nationally

 

Minimum requirement of academic education

BSc in a life-science discipline

 

Work location & travel

Home-based; Germany; travel as needed

 

FTE

Full-time (part-time possible)

 

NOTE: Phortas does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to Phortas employees is strictly prohibited. Unsolicited referrals and resumes sent to Phortas are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired.

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