Position: Associate Director of Regulatory Affairs
The Associate Director of Regulatory Affairs will manage all regulatory activities, ensuring timely preparation of organized and scientifically valid submissions, particularly nonclinical, Chemistry, Manufacturing and Controls (CMC), safety and clinical information required as part of INDs, BLAs, NDAs and CTDs in support of the investigational drugs in the Biothera portfolio. This position will also assist the in developing regulatory strategies and associated activities supporting the development of portfolio products. The position reports to the Director of Regulatory Affairs.
Essential Functions:
1. Serve as the lead Regulatory Affairs Representative on all projects; such as, clinical working groups; (supply to sites; chemistry, manufacturing and controls) and others as requested.
2. Supervise and/or participate in gathering information and assembling regulatory documentation for the filing of an electronic IND, BLA and NDA such as; annual reports for drugs and biologics, clinical amendments; such as clinical protocols, clinical investigator information; response to clinical request for information, CMC, and nonclinical amendments to INDs, BLAs and NDAs.
3. Provide project plans and timelines for significant regulatory activities. Ensure that plans are managed for optimal integration of timing, scope and resources. Review regulatory documents for quality and accuracy, and assure submission timelines meet statutory requirements.
4. Contact FDA divisions as needed and communicate within Biothera promptly and clearly, information shared by FDA or requests for information. Document appropriate communications per SOP’s. Lead regulatory efforts with FDA.
5. Back up the Drug Safety Associate on an as needed basis to assure that all adverse events are submitted in accordance with the statutory requirements.
6. Expand knowledge of laws, regulations and guidelines governing drug development and approval. Share learning’s from new guidance’s or best practices within the department and to Biothera personnel.
7. Back-up the Regulatory Associate function and assure that established regulatory affairs practices and policies are adhered to. As appropriate, identify enhancements or modifications to processes as necessary.
8. Represent Biothera with a high level of integrity and professionalism.
9. Adhere to Biothera’s policies and support management decisions and goals in a positive and professional manner.
Knowledge, skills and Abilities Required:
1. Excellent written and oral communication skills; ability to communicate effectively and project a professional image when giving and taking information in writing, in person, and over the phone.
2. Display of confidence and calmness during FDA interactions.
3. A good understanding of the processes involved in early stage research, preclinical development, clinical research, process development, manufacturing, quality assurance and quality control, and marketing.
4. Good interpersonal skills and ability to lead and work with co-workers and outside agencies professionally and tactfully.
5. Ability to take initiative and prioritize tasks; good time-management, problem-prevention, and problem-solving skills.
6. Ability to independently exercise judgment in developing methods and criteria for determining appropriate action to obtain objectives.
7. Strong analytical ability with active listening skills.
8. Ability to work accurately with close attention to detail.
9. Ability to maintain confidentiality of sensitive information.
10. Experience with electronic regulatory submissions.
Qualifications:
1. Bachelor’s degree in Science, Health Care or related field, or equivalent related experience.
2. Six (6) to ten (10) years of experience in biotech/pharmaceutical industry, with at least four (4) years of regulatory affairs experience and managing cross-functional drug development projects.
Contact:
Send resume to jobs@biothera.com. No calls please.